Reversible Intra-vas Device

Abstract

A device is disclosed for blocking body passages, having special application in the vas deferens for preventing the flow of sperm from the testis to the seminal vesicle. The device is maintained in place by one or more sutures, ligatures, or clips. If desired, the device may subsequently be removed.

Description

The present invention relates to a novel means for blocking a body passage. The device has particular application in sterilization of the human male wherein the device is inserted into the vas deferens to effectively block the flow of sperm from the testis to the seminal vesicle. It may later be removed, thereby rendering the male fertile again.

In the male reproductive system, sperm are produced in the testis. The sperm travel through the epididymis and then up through the vas deferens to the seminal vesicle where they are combined with a carrier fluid. This fluid then travels to the ejaculatory duct and is ejaculated during copulation. The device of the present invention prevents sperm from traveling from the testis to the seminal vesicle, by blocking off the vas deferens at some point between the tail of the epididymis and the seminal vesicle.

It has previously been known that the vas deferens can be sealed off to prevent the flow of sperm and thus render the male sterile. One method of performing this has been to simply ligate the vas deferens securely or transect the vas deferens or transect and resect a segment of the vas. This method has an inherent disadvantage in that it is very difficult, and frequently impossible, to later render the male fertile again. The difficulty arises from the fact that when an attempt at joining (anastomosis or vasovasotomy) occurs, the results of restoring the continuity and patency of the vas are very poor. Since the wall of the vas deferens is quite thick in relation to the interior diameter thereof restorative surgery to again permit the flow of sperm is infrequently successful due to stenosis.

There have been other attempts to block the vas deferens with various types of plugs. However, these plugs are always the same size and as a result they are not always successful to prevent the flow of sperm. It has now been discovered that in order to prevent the flow of sperm, the blocking device must completely shut off the vas deferens. If even one sperm passes the blocking device, the entire purpose of the blocking device is thwarted. In experiments designed to completely block the flow of sperm, it has been discovered that the vas deferens varies in interior diameter from one male to another and therefore it is important to have the blocking device available in a plurality of sizes, and best results are achieved by linking a plurality of sizes together as will be hereinafter discussed. It has also been discovered that tying means such as a ligature, suture, or clip surrounding the vas deferens at the plug will constrict the vas walls tightly against the plug, thereby preventing the sperm from passing. Accordingly, the device of the present invention is an inert plug available in a plurality of sizes which is inserted in the vas deferens through an incision therein. Best results are obtained when it is held in place by one or more sutures, ligatures or clips. The lumen is kept patent due to the presence of a solid occluding device buy yet the vas deferens is completely blocked because the occluding device is the same size as the interior of the vas deferens and the tying means constricts the vas tightly against the blocking device. If removal is desired, the device may be readily located, especially if tying means are employed, and it may be removed by a simple surgical procedure.

The device may be made of any material which is inert in the interior passages of the body. In the practice of this invention, we prefer Teflon because of its proven inertness in the body. It is not necessary, however, that the material be plastic; it may be metal, or glass, or any other material which is inert in the body. The vas deferens varies in interior diameter from 1.0-2.5 mm. depending upon the individual. The device is made in a plurality of sizes between these limits so that a proper fit may be obtained. The various sizes of the device may be individual pieces or for best results they are linked together. The device may be formed by matching molding, casting, or numerous other known techniques.

Insertion of the device in the vas deferens is accomplished by making an incision in the vas deferens at some point between the tail of the epididymis and the seminal vesicle. Because it is a simpler operation, we prefer to choose a point in the scrotal region. The incision is just large enough for the insertion of the device. Since the physician is able to visibly inspect the vas deferens, he is able to select by trial and error a device which is the right size such that it will fit snugly but yet not be difficult to insert. The proper size device thus selected is inserted into the vas through the incision, and the incision is then sutured. For best results, the various sizes of the device are linked together in one piece to form a series of blocking members, as for example, a series of balls in increasing size with linking means between each. A handle can be adjacent the largest ball to facilitate handling the device. The physician in this case is not required to select an individual device of the proper size. He has all sizes in one continuous tapered length and the proper size is selected as being that which fits most snugly in the vas. It will be seen that this has great advantage over trial and error selection of the proper size from a plurality of single pieces since in all cases the proper size is the one that fits most snugly and therefore blocks the vas most completely. The device is then broken off at this point and the excess, i.e., that which is too large to enter the vas is discarded.

The device may also be used for blocking other body passages. It is contemplated, for instance, that the fallopian tubes can be sealed off by means of the device. Other body passages which may be suitably blocked by the device of the present invention will be apparent to those skilled in the field. For body passages other than the vas deferens, the size of the device is varied according to the particular application, and may be as small or as large as is necessary to effectively block the body passage.

Insertion of the device in the fallopian tubes may be through the fimbriated lateral end or though an incision. In either case, the device is so positioned that it is held in place in the medial end of the fallopian tubes. Insertion of the device in other body passages may be by incision or any other suitable means.

To prevent the device from moving, it is fixed into position in the body passage by tying means which may be, for example, one or more sutures, ligatures or clips. As used in the specification and claims, suture is intended to mean one or more strands or fibers which pass through a portion of the body. Ligature is intended to means one or more strands or fibers which surround a body tube. Clip is intended to means a clip which surrounds the body tube. Suitable clips are available from Week Surgical Company of Long Island City, New York. Other tying means may also be used.

The tying means is preferably around the vas at the point of a holding means in the device. The holding means is designed to aid in maintaining the device in position. One satisfactory holding means comprises a "waist" around the middle of the plug. This waist is an indention similar to the constriction in an hour glass. The device is fixed in the body tube by securing one or more ligatures or clips tightly around the exterior of the body tube to press the body tube tightly against the waist, or a suture or suture-ligature may be passed through the body tube to position the device inside the tube. It is preferred to use three ligatures to hold the device in place. Another suitable holding means comprises a hole through the center of the plug. A suture is passed through one wall of the body passage, through the hole, and then through the other wall of the body passage to hold the device in place. A ligature or clip may also be fixed around the body tube, if desired. This method is especially applicable where it is desired to block the fallopian tubes. A third suitable holding means is to make the device of a relatively soft material whereby the suturing needle can carry the suture through the device, thereby holding it in place; alternatively, the suture can pass around the soft material, thereby forming a waist and holding it in place. The soft material must be deformable but it should not be so soft that it will separate into two or more pieces when a ligature is tightly fixed around the outside of the body tube. Alternatively, one or more sutures may be passed through the body tube adjacent each end of the device without unduly constricting the passage. If it is desired to insure that the body tube is completely occluded, an additional ligature or clip may encircle the device and a holding means may be present in the device to accommodate this tying means. Other means for holding the device in place may also be used.

One of the great advantages of the present invention is that the plug may be completely removed at a later date if desired. When the device is removed, the vas deferens or other body tube will usually be somewhat narrower at the site of ligation; however, this will not adversely effect the body tube and it will be capable of functioning again in its normal manner. Removal is simply a matter of incising the vas over the widest portion of the prosthesis, removing the device, and then suturing the incision. When tying means are employed, the place of insertion of the device in the vas may be readily located because of the sutures, ligatures or clips which are used to hold the device in place.

These and other features of the present invention may be more fully understood by reference to the drawings in which:

FIG. 1 is a series of blocking devices linked together;

FIG. 2 is another form of a series of blocking devices linked together;

FIG. 3 is an individual blocking device with a waist;

FIG. 4 is an individual blocking device with a center hole; and

FIG. 5 is another form of an individual blocking device.

FIG. 1 shows the preferred embodiment of the present invention with which best results are obtained and comprises a series of balls 10 joined together by linking means 12. A handle 14 is attached to the end of the series of balls for easy handling of the device. When the vas deferens is the body tube to be blocked, the balls 10 range in size from 1.0-2.5 mm. The largest ball 13 is immediately adjacent to handle 14 and the balls decrease in size down to the smallest ball 15 which is at the opposite end. To insert the device, an incision is made in the vas. The handle 14 is placed between the thumb and the index finger and the smallest ball 15 of the device is inserted into the vas. The device is pushed into the vas until pressure is felt on the thumb and the index finger. The device is then broken off at the linking means 12 immediately above the largest ball which fits into the vas, or if only the smallest ball will fit into the vas, the device is severed at the linking means immediately above the second smallest ball. Alternatively, the deice may be broken off one ball closer to the handle, thereby making longer that part of the device left in the vas deferens. The incision is then sutured and at least one ligature, suture-ligature, clip or other tying means is passed around the circumference of the vas such that it passes over one of the linking means thereby holding the device in place. Suturing of the incision can be either before or after the tying means is placed around the device, and it will be appreciated that in some cases the tying means will also serve to close the incision. It will be noted that the linking means 12 serves as the holding means to maintain the device in place.

The device of FIG. 2 is similar to the device of FIG. 1, but is formed by means of notches 16 located in spaced relationship tapered in a stem 18. The notches 16 may surround the circumference of the stem 18 or they may only extend through a portion thereof. The notches 16 divide stem 18 into segments 20 each of which is similar to the balls 10 of FIG. 1. Insertion is by the same method as in FIG. 1, and the device is severed at a notch 16 in the same manner as the device of FIG. 1 is broken off at linking means 12. The incision is then closed in the same manner as described in the preceding paragraph and the typing means if used is around the vas at the notch 16, which serves as the holding means.

FIG. 3 is an individual blocking device 22 which is provided with a waist 24 which serves as a holding means. In order to insure a tight fit and, therefore, complete blocking of the vas, it is important that this device be available in a plurality of sizes. To insert the device, an incision is first made in the vas. The physician by trail and error selects a device which he believes to be of the proper size such that one of the ends 26 will fit snugly in the vas but will not require an undue amount of pressure to be inserted. The selected device is inserted, and the vas is sutured, with at least one tying means passing around the vas at the point of the waist thereby holding the device in place.

FIG. 4 shows an individual blocking device 28 wherein the holding means comprises a hole 30 through the center of the device. In order to insure a snug fit in the body tube, it is important that a plurality of sizes of the device be available. To insert the device, an incision is made in the wall of the body tube, and a device of the proper size is selected by trail and error such that it will fit snugly in the body tube but will not require an undue amount of pressure to insert. The device 28 is placed in the body tube with the hole 30 running transversely to the direction of flow of the body tube. The body tube is then sutured and at least one suture is passed through the wall of the body tube, through the device by means of the hole, and then through the other wall of the body tube, thereby holding the device securely in place.

The device of FIG. 5 is in the shape of the interior of the body tube which it is to block. In the case of the vas deferens, this would be essentially a cylindrical shape 32. The device is held in place by means of sutures which pass through the body tube at the ends of the device thereby preventing the device from moving in either direction. In body tubes where it is desired to completely block the passage of a body fluid, such as in the vas deferens, a ligature or clip may encircle the body tube at the device and constrict the body tube such that it is in contact with the blocking device thereby completely blocking the body tube. In any application where it is desired that the device may subsequently be removed, it is important that the sutures at the ends of the device which hold it in place not constrict the body tube of themselves but serve only to prevent the device from appreciably moving laterally along the body tube.

It will be understood that it is intended to cover all changes and modifications of the preferred embodiments of our invention, herein chosen for the purpose of illustration, which do not constitute departure from the spirit and scope of our invention.

Claims

What is claimed is:

1. A device for blocking the vas deferens which comprises a series of at least three blocking members in a plurality of sizes, said members being joined together by linking means, said linking means being of smaller cross-section than said blocking members and serving to aid in separating said blocking members, said linking means being adapted to serve as a holding means in the vas deferens.

2. The device of claim 1 wherein the blocking members are essentially round.

3. The device of claim 1 wherein the blocking members range in size from 1.0 - 2.5 mm. and in which there are a minimum of five blocking members.

4. The device of claim 1 which includes a handle on one end of said blocking members.

5. The method of blocking the vas deferens with a series of connected blocking members which comprises the steps of:

a. making an incision in the vas deferens, said incision being at least about as large as the interior diameter of said vas deferens,

b. inserting a series of blocking members connected by linking means, said linking means being of smaller cross-section than said blocking members and serving to aid in separating said blocking members and said linking means being adapted to serve as holding means through said insertion into said vas deferens until at least one of said blocking members fits snugly in the vas deferens, and

c. closing said incision and having at least one tying means constricting said vas deferens against the said series of blocking members.

6. The method of claim 5 wherein the tying means is selected from the group consisting of sutures, ligatures, and clips.

7. The method of claim 5 wherein after step (b) a part of the series of blocking members is separated from the rest of the blocking members and discarded.