GB2076293A

GB2076293A - A device for developing control of sphincter-type muscles

Info

Publication number: GB2076293A
Application number: GB8101035A
Authority: GB
Original assignee: Craig Medical Products Ltd
Current assignee: Craig Medical Products Ltd
Priority date: 1980-05-20
Filing date: 1981-01-14
Publication date: 1981-12-02

Abstract

A device for assisting a person to exercise and improve his or her control of sphincter-type muscles comprises a hollow elongated support member 80 which carries or in part defines a hollow cuff 86. The interiors of the member and the cuff are in communication with each other and are filled with a working fluid. There is a plug socket 83 located at one end of the member 80 and a plug 90 containing a pressure transducer 94, 96 located in the socket in such a way that the transducer senses changes in the pressure of the working fluid caused by the user exercising a muscle with which the cuff 86 is in contact. The longitudinal extent of the cuff 86 is preferably less than a quarter of that of the member 80. The working fluid may be a silicone liquid.

Description

SPECIFICATION A device for developing control of sphincter-type muscles This invention relates to a device for assisting a person to exercise and strengthen and improve his or her control of certain internal muscles herein called sphincter-type muscles.

In this specification, the term "sphinctertype muscle" is used to mean any internal muscle in the human body which plays a part in controlling the excretory functions. Examples are the anal sphincter muscle and the levatores ani group of muscles of the pelvic floor, in particular the pubococcygeus muscle.

It has been suggested that the muscles around the urethral-vagina area in women can be stimulated electrically, so causing the muscles to contract and control discharge of urine. Devices with small electrodes have been proposed but are in general expensive and not popular with users. An example of this kind of device is shown in U.S. Patent Specification 3 640 284 of DE LANGIS.

The present invention is based on a different approach, namely assisting the patient to develop a mental control over the relevant muscles, so as to help him or her to control incontinence. A patient who is trying to develop this control must have a clear feedback of his or her success or failure, and to the best of the Applicants present knowledge and belief, no fully satisfactory device for giving such a feedback exists. KEGEL in U.S. Patent Specifications 2 507 858 and 2 541 520 suggests methods and a device for indicating or observing the exercising of injured sphincter muscles. The KEGEL device has a core and a a laterally-extending vulcanised rubber disc which forms a stop to limit the extent of insertion. A flexible and expansible bulb surrounds the core.In use, the device is inserted up to the stop and the bulb is inflated by hand, by the user, to bring its wall into engagement with the wall of the muscle of interest. A pressure gauge connected to the interior of the bulb is then used to monitor compression of the bulb achieved by the efforts of the user in intentionally contracting the muscle of interest. This device has achieved a certain amount of practical use but is not popular among users because it is uncomfortable to insert and to use. Moreover, the results obtained often are not sufficiently specific to a particular muscle of interest.

Developments of this general concept are disclosed in U.S. Patent Specifications 3 502 328 (HAMILTON), 3 726 272 (COLE) 3 752 150 (HARRIS), 3 926 178 (FELDZAMEN), 4 048 985 (SASSE), 4 050 449 (CASTELLANA ET AL), 4 167 939 (REMIH), 4 216 783 (KAISER ET AL), and British Patent Specifications Numbers 1 319 228 (BUNING) and 1 532 360 (REMIH). A problem remains in that a patient using such a device without close medical supervision may over-inflate, and if different levels of inflation are used at different times (and it will be very difficultto avoid doing this in practice) the results obtained at one time are not comparable with those obtained at another time.The user's sense of achievement, which is an important factor in this kind of treatment, is thus frustrated and an average user will be confused in interpreting the results. Hence the desired improvement in muscle tone may not be achieved because the user loses confidence in the device. It has been proposed e.g. in the BUN ING Patent mentioned above, to use a prefilled device. This avoids the problems of overinflation and different amounts of inflation.

In a prefilled device which is intended for use by relatively unskilled and non-medical persons, it is desirable that setting up for operation should be simple and a clear readout should be given.

According to the present invention, a device for assisting a person to exercise and improve his or her control of sphincter-type muscles comprises a hollow elongated support member which carries or in part defines a hollow cuff, the interiors of the member and the cuff being in communication with each other and filled with a working fluid, there being a plug socket located at one end of the member and a plug containing a pressure transducer located in the socket in such a way that the transducer senses changes in the pressure of the cooking fluid caused by the user exercising a muscle with which the cuff is in contact.

According to a particular embodiment of the invention, the device includes a tube forming the elongated support member and having an annular cuff near its free end. The longitudinal extent of the cuff is preferably less than a quarter of that of the member. Both cuff and member are prefilled with suitable fluid, e.g. a silicone liquid. The interior of the cuff and the tube are in communication through one or more holes. A flange is preferably included to facilitate proper adjustment of the position of the device when inserted, so that the cuff is in registry with the muscle of interest.

The tube may be reinforced in any suitable way to give it a degree of stiffness while not being rigid such that it can be inserted comfortably in the vagina, and its distal end may be closed and rounded. The tube may be made of latex rubber by a dipping process.

The invention will be better understood from the following non-limiting description of an example thereof given with reference to the accompanying drawings in which: Figure 1 is a side elevation illustrating one example of a device according to the invention, and Figure 2 is an axial cross-section of one end of the device shown in Fig.1.

The device illustrated in Fig. 1 has a hollow latex tube 80 with a rounded end 82, its wall being of appropriate thickness or suitably reinforced (for example as described below) to give the tube a stiffness so that it can be readily inserted without discomfort and yet has sufficient rigidity not to be deformed by the muscle movements. The tube 80 has a thin flexible and expansible annular rubber latex wall 84, defining with the tube 80 an annular cuff 86. A hole 88 is provided in the wall of the tube 80 leading into the interior of the annular cuff 86. More than one hole 88 may be provided. The tube 80 and the cuff 86 are both pre-filled with a suitable fluid such as a silicone liquid, this being retained within the tube by a diaphragm wall 91 (Fig.

2) extending across the tube 80 near its open end. The open end 83 forms a socket designed to receive a plug 90 shown in greater detail in Fig. 2.

The plug 90 has a cylindrical body 92 dimensioned for a snug fit insertion into the open end of the tube 80 and the body carries a pointed probe 93. A pressure-sensing member 94 of a pressure transducer 96, which converts pressure changes into an electrical signal, is located in the probe 93 in such a way that its sensitive face or faces are exposed to and in contact with the liquid 98 within the tube 80. The pressure 94, 96 is located partly within the body 92 and partly within the probe 93, and the latter is pointed so that it can be thrust through the wall 91 when the plug is inserted in the socket. The electrical signal from the transducer 94, 96 is brought out via electrical leads 98. The wall 91 may be made of a stretchable material so that, once penetrated by the probe 93, it tends to make a good liquid seal with the outer surface of the probe 93.The plug 90 has an external cylindrical skirt 100 which surrounds the end of the tube 80 when the plug is applied thereto.

The tube 80 has a flange 102 slidable along it which enables the user to locate the device in the same position each time it is used. As an optional refinement, graduations may be marked on the tube 80 so that the user can note the position of the flange 102 when the cuff 86 is properly located relative to the muscle being exercised.

A device as particularly disclosed and illustrated herein has the advantage that the pressure of the internal liquid is fixed at a desired datum level when the device is made in the factory, and, as it cannot be altered by the user, errors are not introduced from this source. The removable plug arrangement means that the tubular unit comprising the parts 80, 84 and 102 can be a throw-away unit which is sold in a sterilised pack and disposed of after use.

The tube 80 can be made of any suitable material, for example PVC or polyurethane. If desired, a metal wire reinforcement may be included in the tube wall.

The pressure transducer 94, 96 may be connected to an electronic display unit capable of giving either a numerical display of pressure value or a display of lights, for example of different colours, triggered by the achievement of certain pressure values. For example with such a unit it could be arranged, using suitable circuitry the techniques for which are well known in the electronic art, that a given muscle contraction (and hence a given pressure) illuminates a lamp of one colour, a greater contraction illuminates a lamp of a second colour, and a greater contraction still illuminates a lamp of a third colour. Such a unit would preferably include a means of controlling the sensitivity so that the particular levels of pressure at which given lamps are illuminated could be adjusted either by the user, or by a medical auxiliary or a medical practitioner.

Claims

1. A device for assisting a person to exercise and improve his or her control of sphincter-type muscles comprises a hollow elongated support member which carries or in part defines a hollow cuff, the interiors of the member and the cuff being in communication with each other and filled with a working fluid, there being a plug socket located at one end of the member and a plug containing a pressure transducer located in the socket in such a way that the transducer senses changes in the pressure of the cooking fluid caused by the user exercising a muscle with which the cuff is in contact.

2. A device according to claim 1 including a tube which forms the elongated support member and has an annular cuff near its free end.

3. A device according to claim 1 or 2 in which the longitudinal extent of the cuff is less than a quarter of that of the member.

4. A device according to claim 1, 2 or 3 in which the cuff and the member are prefilled with a silicone liquid.

5. A device according to any one of claims 1-4 in which the interior of the cuff and the tube are in communication through one or more holes and a flange is carried by the elongated support member and is slidable therealong, to facilitate adjusting the position of the cuff in use in registry with the muscle of interest.

6. A device according to any of claims 1-5 in which the tube is reinforced to give it a degree of stiffness while not being rigid such that it can be inserted comfortably in the vagina, and the distal end of the tube is closed and rounded.

7. A device according to claim 6 in which the tube is made of latex rubber by a dipping process.

8. A device for assisting a person to exer cise and improve his or her control of sphincter-type muscles substantially as herein described with reference to and as illustrated in the accompanying drawings.