EP0088173B1

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Publication number: EP0088173B1
Application number: EP82301130A
Authority: EP
Inventors: Seymour W. Shapiro
Original assignee: Bivona Inc
Current assignee: Bivona Inc
Priority date: 1982-03-05
Filing date: 1982-03-05
Publication date: 1987-07-29
Also published as: DE3276851D1; ATE28573T1; EP0088173A1

Abstract

Device (1) for use in exercising the vaginal muscles, embodying a cuffed rod (2) for insertion into the vagina, the cuff being normally yieldingly inflated for affording a yielding resistive force, but being collapsible for insertion into the vagina.

Description

This invention relates to a device for exercising the vaginal muscles, the device being of the kind comprising an elongate rod means have a closed distal end portion for insertion into the vagina of a female, and a proximal end portion for manually retaining said distal end portion in said vagina; and a cuff mounted on said distal end portion and comprising a flexible tubular cover disposed on said elongate rod means in surrounding relation thereto, and being secured to the outer surface of said rod means, the cuff being expansible and contractible between a contracted position, for movement of said distal end portion and said cuff into said vagina, and an expanded position, for yieldingly engaging the walls of such a vagina in which said distal end portion and said cuff are disposed, and in which position the cuff is collapsible inwardly by said walls upon contraction of the vaginal muscles by said female.
Weakness of the muscles of the pelvic floor, which support the vaginal walls, is common among adult female population, and particularly among those who have borne children. Advanced degrees of weakness of these muscles culminate in loss of support of the bladder, urethra, rectum and uterus.
Exercise is a well established means of obtaining and maintaining muscle fitness. Exercises may be classified into passive, active and resistive categories. Resistive exercises require the use of muscles against a force which, commonly, is relatively small at the beginning of an exercise program and gradually increases as the muscle tone and strength increases.
A known exercising device of the kind referred to is disclosed in US―A―3752150. However in this known device the cuff is filled with liquid and positive pressure is applied to inflate the liquid- filled cuff before and/or after insertion of the device into the vagina of a female.
Other known exercising devices have been heretofore known in the art as exemplified in US-A-2,507,858, US-A-2,541,520, US-A-3,598,106, US―A―3,726,273, US―A―4,048,985, US―A―4,050,449 and US―A―4,106,489. However each of these known devices has commonly had several inherent disadvantages, such as, for example, being difficult to insert into the vagina; being painful to -insert into the vagina or being painful in use during exercising of the vaginal muscles; being so constituted and arranged as to create danger of injury to the vagina during insertion thereinto and/or during use therein; or creating a maximum initial pressure against the vaginal walls, which, in the use thereof, can be the cause of injury or damage to such walls, and the like and also, because the compositions of such devices are latex or rubber, such materials are irritative to human tissues and difficult to clean and maintain for repeated use.
It is an aim of the present invention to overcome the above mentioned disadvantages and to provide an exercising device for use in the resistive exercising of vaginal muscles.
In addition it is an aim of the present invention to provide an exercising device of the kind referred to, which when inserted into position of use in a vagina, exerts a soft, yielding minimal pressure or force against the vaginal walls, which force increases as the vaginal muscles are exercised and contracted.
According to the present invention a device of the kind referred to for exercising the vaginal muscles, is characterised in that the cuff further comprises a resilient body portion mounted in said cover, said body portion having normally an expanded condition, wherein it is effective to hold a portion of said cover outwardly away from said rod means under atmospheric conditions so that the cuff is in its expanded position, and means operatively connected to said cover for creating an at least partial vacuum therein to move said cover inwardly, against the resilient urging of said body portion, so that the cuff is moved towards or into its said contracted position and for releasing such an at least partial vacuum in said cover to thereby permit said cover to move outwardly under urging of said body portion so that the cuff is moved towards or into its said expanded position to provide a minimal resistive force against the walls of the vagina.
A female when using an exercising device according to the invention is able to recognize the degree of muscle activity being exerted by her own sensations. If desired the device may embody a measuring device for indicating the amount of muscle contraction taking place during exercise by measurement of the volume of displaced air from the device.
Embodiments of the invention will now be described, by way of example, with reference to the accompanying drawings, in which

FIG. 1 is a fragmentary, side elevational view of a device embodying the principles of the present invention, to illustrate the presently preferred embodiment of the present invention, and showing the device connected to a vacuum pump or syringe;
FIG. 2 is a view similar to FIG. 1, but showing part of the device in a different position, and showing the vacuum pump in actuated position;
FIG. 3 is a view, similar to FIG. 2 but showing the device being inserted into a vagina;
FIG. 4 is a view similar to FIG. 2, but showing the device inserted into the vagina and in operable position relative thereto;
FIG. 5 is a detail sectional view taken substantially along the line 5-5 in FIG. 1;
FIG. 6 is a fragmentary, side elevational view of a modified form of the present invention;
FIG. 7 is a detail sectional view taken substantially along the line 7-7 in FIG. 6; and
FIG. 8 is a fragmentary, side elevational view of the device shown in FIG. 1, showing the device attached to a pressure gauge.

Description of the EmbodimentsShown Herein

An exercise device 1, embodying the principles of the present invention, is shown in the drawings to illustrate the presently preferred embodiment of the present invention.

The exercise device 1 embodies, in general, anelongate rod 2 having adistal end portion 3 and aproximal end portion 4, with acuff portion 5 mounted on thedistal end portion 3, FIGS. 1-4.

Therod 2, preferably, is semi-rigid and flexible- pliable in construction, and may be made of several suitable materials, such as, preferably medical grade silicone which does not react to human tissue. As will be discussed in greater detail presently, in the use of the device 1, thedistal end portion 3 of therod 2, with thecuff 5 attached thereto, is inserted into the vagina of a female, theproximal end portion 4 of the device 1 affording a member by which the device 1 may be manually retained in such position in the vagina. Thefree end 6 of thedistal end portion 3 preferably is rounded, to facilitate such insertion of the device into the vagina, and as protection against injury to the female during such insertion into the vagina and during the time the device is retained therein.

Thecuff portion 5 includes a substantially air impervious medicalgrade silicone cover 7 and a body portion 8 disposed within thecover 7. Both thecover 7 and the body portion 8 are disposed around thedistal end portion 3 of therod 2, preferably in spaced relation to theend 6 thereof.

Thecover 7 is flexible and it is preferably made of medical grade silicone or the like. Preferably, it also is elastic for reasons which will hereinafter be discussed in greater detail. Preferably, thecover 7 is comprised of a suitable elastic material such as the aforementioned medical grade silicone.

Thecover 7 is tubular in form, and the

end portions

9 and 10 thereof are hermetically sealed to the outer surface of therod 2 by suitable means, such as, for example, being vulcanized thereto or by a suitable medical grade cement such as silicone cement, or the like.

The body or sponge portion 8 affords a resilient mass which preferably completely fills thecover 7 between the

end portions

9 and 10 thereof and, when the exercise device is disposed in normal inoperative position, outside the vagina, the sponge portion is preferably effective in yieldingly holding thecover 7 in fully expanded position, as shown in FIG. 1. The body or sponge portion 8 may be made of any suitable resilient material, but, preferably, is made of several grades or densities of a spongelike resilient material having a multitude of interstices spread therethrough, such as, for example, sponge-type silicone or a suitable resilient plastic material, such as, for example, foamed polyurethane, or the like, for a purpose which will be discussed in greater detail presently.

From the foregoing it will be seen that thecuff portion 5 is similar in construction to the cuffs embodied in the tracheal tubes disclosed in US-A-3,640,282 and US-A-3,799,173.

Anelongate passageway 11 extends longitudinally through therod 2 from thefree end 12 of theproximal end portion 4 thereof into the interior of thecuff 5, terminating at itsinner end 13 in inwardly spaced relation to thefree end 6 of thedistal end portion 3.Passageways 14 extend radially outwardly from thepassageway 11, through therod 2 and open outwardly into the interior of thecuff 5 for the purpose which will be discussed in greater detail presently.

Anadapter 15, embodying an elongatetubular body member 16 is mounted in theproximal end portion 4 of therod 2, with one end portion of thebody member 16 disposed in thepassageway 11, FIGS. 1-4. Theadapter 15 also includes aplug 17, attached to thebody portion 16 by aflexible strap 18, theplug 17 being movable on thestrap 18 between a position wherein it is disposed in thefree end portion 19 of thebody portion 16 of theadapter 15 to thereby close thepassageway 11 and thebody portion 16 to the atmosphere, as shown in FIG. 3, and a position wherein it is disposed out of theadapter 15, as shown in FiGS. 1, 2 and 4.

With the exercise device 1 constructed in the aforementioned manner, when it is desired to insert it into a vagina, such as thevagina 20 diagrammatically shown in FIGS. 3 and 4, a partial vacuum may be applied to thefree end 19 of theadapter 15 by any suitable means, such as, for example, a vacuum syringe P, shown in FIGS. 1 and 2, to thereby cause thecuff portion 5 to move from its normal expanded position, shown in FIG. 1, to a collapsed position as shown in FIGS. 2 and 3. After thecuff portion 5 has thus been collapsed, the passageway through theadapter 15 and the

passageways

11 and 14, into the interior of thecuff 5, may be closed by any suitable means, such as, for example, by first pinchingtubular member 16 to close the same, then withdrawing the syringe P from theadapter 15, and immediately closing theend portion 19 of thetubular member 16 by a finger, or the like. However, in the preferred form of the present invention, such closing of theend portion 19 is effected by inserting theplug 17 thereinto, as shown in FIG. 3. This, it will be seen, is effective to retain the partial vacuum in thecuff 5 and, therefore, retain it in the collapsed position shown in FIG. 2 and 3.

While thus maintaining the vacuum in thecuff 5, thedistal end portion 3 and thecuff 5 may be inserted into a vagina, such as thevagina 20, FIG. 3, the collapsed position of thecuff 5 facilitating such insertion. Preferably, this insertion of the device 1 is such that thecuff 5 is disposed in position within the sphincter type muscles in the vaginal area. Thereafter, when the device 1 has been moved into the desired position in thevagina 20, the partial vacuum in thecuff 5 may be released to thereby permit thecover 7 to be pushed and expanded outwardly by the expansion of the resilient sponge body member 8. The expansion of thecover 7 is from the collapsed position to a position wherein it is yieldingly positioned within the body portion 8 in engagement with theinner wall 21 of thevagina 20, FIG. 4. Such movement and expansion, it will be seen, is caused by the resiliency of the sponge body portion 8 and is a direct result of the volumetric expansion thereof. Importantly, the density of the sponge body portion 8 may be varied to provide different grades or amounts of yielding pressure gradients within each exercise device. This is to be distinguished from the expansion of the aforementioned cuffs on exercise devices heretofore known in the art, which cuffs are expanded by the application of a positive pressure, by the introduction of air or other working fluid thereinto under pressure. Such devices therefore start with the largest force upon initial contact with the vaginal muscles.

It will be remembered that thecover 7 of thecuff 5 may be made of any suitable flexible material, but preferably is medical grade silicone. When so constructed, the cover comprised of medical grade silicone is so constructed that the wrinkles that are formed therein when in the collapsed position, as shown in FIGS. 2 and 3, are soft and minimize abrasive tendencies with the vaginal muscles. Whereas with some materials which are flexible but do not possess softness and which are abrasive, such as, for example, certain plastic or rubber sheet materials, and the like, wrinkles could be formed when thecover 7 is disposed in a position wherein it was extended outwardly less than that which it occupies when in fully extended position. Thus, it is not essential as to whether or not thecover 7 is wrinkled when thecuff 5 is in fully collapsed position, as shown in FIGS. 2 and 3, and it is not essential nor an absolute requirement, when thecuff 5 is disposed in operative engagement with the walls of a vagina, such as is shown in FIG. 4, that thecover 7 be wrinkle free. However, it is preferred that thecover 7 be structured and sized to substantially envelope the sponge portion 8, when thecuff 5 is in operative engagement with a vagina, as shown in FIG. 4. Therefore, to ensure against such abrasive wrinkles, we prefer that thecover 7 be made of a suitable material such as medical grade silicone.

With device 1 thus disposed in operative position in the vagina of a female, the female may contract her pelvic floor muscles against the urging of the body portion 8 of thecuff 5. This, it will be seen, is a gentle, yielding urging, which, unlike cuffs of exercise devices heretofore known in the art which are inflated with fluids which provide unyielding positive pressure preventing cuff compression, does not exert a positive pressure against the sidewalls of the vagina, which positive pressure is in danger of injuring delicate membranes such as the sidewalls of the vagina. Instead, the present invention begins with a minimal resistive force which increases as contraction increases. The present invention thus provides a cuff that can be compressed by muscle action and which requires increasing muscle forces to increase the compression, thus resulting in a resistive muscle exercise.

It is important to note that the use of the device 1, in pelvic floor muscle exercise, provides not only a resistive exercise for such muscles, but also provides progressively increasing resistance as the body portion 8 of thecuff 5 continues to be compressed. Thus, it will be seen that the device 1 is capable of exerting a small minimal resistive force at the beginning of an exercise program, when the muscular tone and strength is relatively weak, while affording a gradually increasing resistive force as the muscular tone and strength increases. Also, with this increasing resistance by the body portion 8 of thecuff 5, the female using this device is able to recognize this increasing resistance by her own sensations, and thus realize that the exercises are being effective in building up the tone and strength of her pelvic floor muscles.

At the completion of the exercises, the device 1 may be manually removed from the vagina. Preferably, prior to such removal, a partial vacuum is again applied to thecuff 5 in the aforementioned manner, to thereby dispose thecuff 5 in partially or totally collapsed position, as shown in FIGS. 2 and 3, to facilitate removal of the device 1.

Although therod 2 is shown in FIGS. 1-5 of the drawings as embodying thepassageway 11 as an integral part thereof, it will be appreciated by those skilled in the art that this is merely by way of illustration of the preferred embodiment of the present invention, and not by way of limitation, and that other passageways may be afforded without departing from the purview of the broader aspects of the present invention. For example, instead of therod 2, a solid semi-rigid butflexible rod 2a, as shown in FIGS. 6 and 7, may be used, and a separate tube, such as atube 22 having apassageway 11a therethrough may be substituted therefor.

Also, it will be seen that, with the device 1 constituted and arranged in the aforementioned manner, if it is desired to do so, a measuring device may be associated therewith for measuring the performance of the female in contracting her pelvic floor muscles, rather than the aforementioned reliance on her own sensations as to the increasing resistance of the-body portion 8. For example, as illustrated in FIG. 8, a volume displacement measuring device, such as an air gauge means 23, may be secured to theend portion 19 of thetubular body portion 16 of theadapter 15 by a suitable conduit, such as atube 24, thegauge 23 being capable of measuring the air flow from within thecuff 5, thepassageway 11 and theadapter 12 caused by the contraction of the vaginal muscles of the female; greater contraction, of course, causing higher air flow. If desired, the user of the device can even place a finger adjacent to theopening 19 and physically feel and sense the airflow upon contraction of the vaginal muscles.

Claims

1. A device (1) for exercising the vaginal muscles comprising: an elongate rod means (2) having a closed distal end portion (3) for insertion into the vagina of a female, and a proximal end portion (4) for manually retaining said distal end portion (3) in said vagina; and a cuff (5) mounted on said distal end portion and comprising a flexible tubular cover (7) disposed on said elongate rod means (2) in surrounding relation thereto, and being secured to the outer surface of said rod means (2), the cuff (5) being expansible and contractible between a contracted position, for movement of said distal end portion (3) and said cuff (5) into said vagina (20), and an expanded position, for yieldingly engaging the walls (21) of such a vagina in which said distal end portion (3) and said cuff (5) are disposed, and in which position the cuff (5) is collapsible inwardly by said walls upon contraction of the vaginal muscles by said female, characterised in that the cuff (5) further comprises a resilient body portion (8) mounted in said cover (7), said body portion (8) having normally an expanded condition, wherein it is effective to hold a portion of said cover (7) outwardly away from said rod means (2) under atmospheric conditions so that the cuff (5) is in its expanded position, and means (P, 11, 16) operatively connected to said cover (7) for creating an at least partial vacuum therein to move said cover inwardly, against the resilient urging of said body portion (8), so that the cuff (5) is moved towards or into its said contracted position and for releasing such an at least partial vacuum in said cover to thereby permit said cover to move outwardly under urging of said body portion so that the cuff (5) is moved towards or into its said expanded position to provide a minimal resistive force against the walls of the vagina (20).

2. A device according to claim 1, in which said means (P, 11, 16) connected to said cover (7) comprises a passageway (11) extending longitudinally of said rod means (2) from its proximal end into said cover for passage of air therethrough during said creation and release of said at least partial vacuum.

3. A device according to claim 1 or claim 2, in which said body portion (8) has interstices spread therethrough.

4. A device according to any of the preceding claims, in which said body portion (8) comprises a spongelike elastic mass mounted in said cover (7) for yieldingly urging the latter outwardly.

5. A device according to claim 2, or claim 3 or 4 when dependent upon claim 2, which includes means (18) for closing said passageway (11) for thereby holding said at least partial vacuum in said cover during insertion of said distal end portion (3) and said cuff (5) into said vagina.

6. A device according to claim 5, in which said means (18) for closing said passageway comprises a plug (17) attached to said proximal end and movable into and out of said passageway (11 ).

7. A device according to claim 2 or any of claims 3 to 6 when dependent upon claim 2, which includes a volume displacement indicator means (23) connected to said passageway (11) for measuring the force with which said cover (7) is collapsed by said contraction of said vaginal muscles.

8. A device according to any of the preceding claims, in which said rod means (2) is flexible and pliable.

9. A device according to any of the preceding claims, in which said body portion (8) comprises polyurethane foam rubber, and said cover (7) comprises medical grade silicone.