Inflatable Leakage Inhibitor

Abstract

An inflatable balloon-like bulb attached to the end of a check-valved catheter tube, removably attachable to an inflating bulb, with a stop means slidable along the catheter tube, the arrangement being such that when the balloon is deflated on the end of the catheter tube, it may be inserted through the urethra into the bladder, then inflated by the bulb, and held in that position by the sliding stop pushed up against the urethral outlet walls to hold the inflated balloon in sealing relationship. The device also may be used in like manner to seal the rectum.

Description

BACKGROUND OF THE INVENTION

Heretofore one of the problems of people, particularly older women, is urinary incontinence and also there is a problem of bowel incontinence of both sexes. Various bags and the like have been used in the effort to overcome these problems. It is particularly difficult to seal off the outlet of an internal opening and especially to do so with a device which can be handled readily by the patient or an attendant in a hospital or nursing home, and which can be worn without interfering with normal activities of the person, and without being evident. Also the device should be inexpensive so that it can be thrown away and replaced without great cost.

In the drawing:

FIG. 1 is a longitudinal view of this device partly in section;

FIG. 2 is a top view of the clip or stop means enlarged over FIG. 1 and taken approximately on the line 2--2 of FIG. 1;

FIG. 3 is a side elevation of the clip;

FIG. 4 is a vertical section through the clip taken on the line 4--4 of FIG. 2;

FIG. 5 is a view illustrating how the clip may be stretched into release position;

FIG. 6 is a section on the line 6--6 of FIG. 4, slightly enlarged;

FIG. 7 is a section on the line 7--7 of FIG. 4, slightly enlarged;

FIG. 8 is an elevation of the two metal inserts in the clip;

FIG. 9 is a top plan view of FIG. 8; and

FIG. 10 is a schematic abdominal female section.

DESCRIPTION OF THE PREFERRED EMBODIMENT

In the drawings, the dimensions are altered for clarity as will be evident to those skilled in the medical arts. The device includes a tube 10 such as a catheter tube that is used familiarly in the medical practice, typified by the Foley catheter or the catheter used in circulatory diagnostic practices. These tubes are flexible but stiff enough to be pushed through the passages and body tubes such as the urethra. Typically they may be about one-tenth of an inch in outside diameter. As shown, the tube 10 has a plurality of holes 11 at its end, here called the upper end for convenience. These holes communicate to an interior axial passage running the length of the tube.

The tube 10 in the present invention has a flexible balloon 12 of thin elastic material over its end, covering the holes 11 and sealed around the outside of the tube 10 by a seal 13. By this arrangement, the balloon 12 constitutes a sealed chamber open only to the interior axial passage of the catheter tube 10.

At the other end, the catheter tube 10 has a fitting 16 incorporating a check valve that can prevent expulsion but permit introduction of air. Typically, this is a ball check valve that seats downwardly (as viewed in the drawing) but can be dislodged from its closing position by either air from below or by a wire. There is also a further fitting 17 that is on the end of hand-operable pumping or syringe bulb 18. By this fitting 17, the bulb 18 can be screwed onto the end of the catheter tube 10 or readily removed therefrom. All of these fittings can be quite small, and, indeed, fittings as presently appearing on catheter tubes are only perhaps twice the diameter of the tube itself.

In addition, there is a stop or clip 20 that can slide along the catheter tube 10 but be disposed in a clamping position preventing it from sliding. This can be arranged by known clamping means, but it is preferred to have it inexpensive and easy to operate.

As here shown, the stop consists essentially of an elastic member 21, elongated and preferably turned to correspond to an anatomical shape appropriate to its use, and having depending end finger projections 22. It also has a central vertical bore 23 through it to receive the catheter tube 10. This bore preferably tapers downwardly as illustrated in FIG. 4.

The clip must be firmly urged into engagement with the tube 10 when released, and downward forces on its ends must not cause it to release, and preferably should make it tighten. It should be manually releasable, either by hand or by use of a suitable hand tool. The present illustration shows such a clip, the plastic body 21 being of rubber or like material, capable of being resistingly deformed, as by spreading the finger elements 22. Embedded in the body 21 are two opposed metal elements 26 and 27 that are like in shape but oppositely faced, so that they have corresponding reference numbers.

The cross sectional shape of the abutment elements can be seen in FIG. 7. There the element 26 has an upper flange 28, offset to the rear of the tube passage 23. The flange 28 has a rocking edge 29 that is located in rockable contact with the corresponding rocking edge on the facing abutment element 27. The flange 28 is connected by a horizontal ledge 30 with a depending and clamping flange 31 that has a tube-engaging point or tip 32. The two somewhat pointed clamping flanges 32 are located medially of the elastic body 21 and extend into the tube passage 23 on opposite sides thereof. When the body 20 is released, the clamping tips 32 come close enough together to grasp the tube and hold the clip 20 against downward displacement.

In use, the bulb 18 is threaded onto the fitting 16, the clip or stop 20 is drawn down toward the bulb the distance of several inches from the seal 13 of the now deflated balloon, and the upper end is inserted into the urethra 40. Lubricant can be applied as necessary. When the balloon portion is well within the bladder 41, the bulb 18 is squeezed, it having the usual check valve arrangement, so that the balloon 12 can be inflated as shown in dotted lines in FIG. 1 and in full lines in FIG. 10.

After the balloon is inflated, the tube 10 is pulled down until the balloon 12 seats and seals against the interior bladder wall around the entrance to the urethra. Then the stop 20 is pushed upwardly until, disposed in a fore and aft direction, it enters the vestibule and engages against the body wall surrounding the urethral outlet. Normally it may be slid into this position without being deformed, since the opening 23 and the edges 22 taper in this direction. The stop 20 is moved up enough to hold the balloon 12 seated in sealing relationship against the lower portion of the bladder adjacent the urethral entrance. When the stop is thus positioned, it cannot slip downwardly because the opposed gripping edges 32 engage firmly against the catheter wall as shown in FIG. 4. Then the bulb 18 is detached and the device will remain in place. Downward forces on the ends of the elastic body 21 cause a firmer engagement of the clip 20 onto the tube 10. The length of the catheter is only sufficient to permit the device to be inserted and held in place in the manner indicated.

To remove the device, it is necessary only for the fingers or an expansion instrument to engage the insides of the finger holds 21 on the clip and force them outwardly as indicated by the arrows a in FIG. 5. This spreads the gripping edges 32 apart, as the halves of the elastic body rock about the rocking edges 29. With the grip released, the clip can be drawn down on the catheter 10, the finger extensions 22 preferably being undercut to facilitate this, as shown. Thereupon, the catheter may be pushed further into the urethra and drainage of the bladder may be performed without full removal of the balloon, which condition may be necessary or desirable, particularly with patients that are bedfast in a hospital. Alternately, the balloon may be deflated by passing a wire into the check valve 16 and the entire device removed.

While this device is illustrated as being particularly useful for female urinary incontinence, it is also evident that it can be used for bowel incontinence in either sex. In such case, the insertion is into the rectum through the anal cavity and is performed in the manner similar to the foregoing and the stop 20 is pressed against the external anal opening.

It is preferred that the components be such that they can be thrown away without great cost. Clearly, the bulb need not be replaced, and the tube 10 may actually thread into the ball check fitting 16. With such arrangement, the only parts that need to be replaced are the tube 10 with the balloon 12 secured thereto, with or without the stop 20. Since the stop 20 can be made as a single molding with the inserts, it is very simple and inexpensive.

One of the features of the present invention also is that the parts are so designed that they will not interfere with the activities of the user. The clip 20 should be designed so that it will not injure the user or cause discomfort. Its actual dimensions can be quite small and it should be narrow so that it can easily slip between the labia. It should be designed without projecting parts that can cause discomfort and should be also designed without parts that can become entangled.

Various changes and modifications can be made within this invention as will be readily apparent to those skilled in the art. Such changes and modifications are within the scope and teaching of this invention as defined by the claims appended hereto.

Claims

I claim:

1. A surgical device of the kind described, comprising: a tube insertable through an external opening of the body communicating by a passage to an internal cavity, an inflatable balloon-like member sealed over the end of the tube with its interior communicating with the axial passage of the tube; releasable means to prevent deflation of the balloon-like member, and stop means slidable along the tube, the stop means having releasable means self-contained in the stop means and engageable at any point along the tube to hold to the tube, to restrain movement of the stop means in the direction away from the balloon-like member, the stop means having smooth surfaces whereby it is comfortable to the user, whereby when the tube and member are inserted through the passage and the balloon-like member is inflated in the cavity, the balloon-like member may be drawn into sealing relation about the entrance of the passage and held there when the stop means is slid along the tube and engaged against the external walls of the passage.

2. In the surgical device of claim 1: a check valve secured to the tube to constitute the means to prevent deflation of the balloon-like member.

3. In the device of claim 2: means for removably attaching an inflater to the end of the tube.

4. In the device of claim 1: the stop means comprising a clip that is made to engage more tightly onto the tube by forces acting in the direction away from the balloon.

5. In the device of claim 1: the stop means comprising a clip that is relatively narrow and elongated so as to span the body opening and fit within the vestibule thereof.

6. In the device of claim 5: the stop being constructed of elastic material having a passage therethrough to receive the tube, the passage having some rigid teeth engageable with the tube and separable therefrom by stretching the elastic of the stop means.