GB2075840A

GB2075840A - A device for developing control of sphincter-type muscles

Info

Publication number: GB2075840A
Application number: GB8101036A
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: 1981-11-25
Also published as: GB2075840B

Abstract

A device for assisting a person to exercise and improve his or her control of sphincter-type muscles includes an elongated support member which carries or in part defines an annular cuff. The member and the cuff are in communication and are filled with a fluid. The cuff is dimensioned and positioned to be capable of sensing small movements of the muscle of interest. The device has means whereby the cuff can be filled to a predetermined pressure with fluid. The said means may consist of a pre-inflated and pre-pressurised bulb or chamber 224 connectible to the interior of the member and hence to the interior of the cuff by a valve 230 located between the bulb and the member. Alternatively the said means may consist of a contractible chamber in fluid communication with the interior of the member via a non-return valve, the chamber being associated with a stored-energy means which upon appropriate triggering, releases its stored energy so contracting the chamber and urging a portion of the fluid therein into the member and the cuff. <IMAGE>

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. The invention is of particular utility in the treatment of female urinary incontinence.

In this specification, the term "sphincter-type 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. 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 Numbers 2 507858 and 2 541 520 suggests methods and a device for indicating or observing the exercising of injured sphincter muscles. The device has a core and 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 manually inflated to bring its wall into engagementwith 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. The results obtained often are not sufficiently specific to a particular muscle of interest. Developments of and variations upon this general concept are disclosed in U.S.Patent Specifications Numbers 3502328 (HAMILTON), 3726273 (COLE) 3752150 (HARRIS), 3926 178 (FELDZAMEN), 4048985 (SASSE), 4050449 (CASTE LLANA PETAL), 4216783 (KAISER ET AL), and British Patent Specifications Numbers 1 319228 (BUNING) and 1 532360 (REMIH).

A device of this kind which is intended for home use by relatively unskilled and non-medical persons desirably should enable a user to obtain results which are not substantially affected by extraneous influences. One factor which often completely spoils comparability between results obtained at different times of use is the extent to which the "bulb" is inflated before the user starts using the muscle exerciser.

According to the present invention, a device for assisting a person to exercise and improve his or her control of sphincter-type muscles includes an elongated support member which carries or in part defines an annular cuff, the member and the cuff being in communication and filled with a fluid, the cuff being dimensioned and positioned to be capable of sensing small movements of the muscle of interest, and the device also has means whereby the cuff can be filled to a predetermined pressure with fluid.

The said means may consist of a pre-inflated and pre-pressurised bulb or chamber connectible to the interior of the member and hence to the interior of the cuff by a valve located between the bulb and the member.

Alternatively the said means may consist of a contractible chamber in fluid communication with the interior of the member via a non-return valve, the chamber being associated with a stored-energy means which upon appropriate triggering releases its stored energy so contracting the chamber and urging a portion of the fluid therein into the member and the cuff.

The elongated support member then preferably has a fluid entry connection by which its interior is directly connected to the pre-inflated bulb or the contractible chamber. The contractible chamber is preferably located with a cylindrical elongated support member.

According to one embodiment of the invention, the support member may be a tube with one closed and one open end, made of latex rubber reinforced over a major part of its length with fibre or cord. This reinforcement is to impart the required stiffness to the tube.

In a preferred version of the invention, the annular cuff is formed by an internal wall constituted by part of the support member and an external wall which is freely stretchable and is of thin latex rubber.

The inflatable cuff may be formed by a hollow annular member of substantially toroidal or "doughnut" shape, having a longitudinal extent of less than a quarter of the length of the elongated support member. By arranging that the cuff is of limited longitudinal (i.e. axial) extent it is possible to secure that a particular selected muscle is monitored, without becoming involved in the complexities of a three-bulb device such as that shown in U.S. Patent Specification 3 726 273 (COLE).

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: Figures land 2 illustrate one example of a device according to the invention, shown in respectively the collapsed and working conditions, and Figure 3 illustrates a second example of a device in accordance with the invention.

The illustrated device for assisting a person to exercise and improve control of sphincter-type muscles illustrated in Figures 1 and 2 has an elongated tubular support member 120 with one end closed and rounded at 122, and an annular expansible cuff defined by an outer stretchable wall 124 and a portion 126 of the wall of the elongated support member or tube 120. Holes 128 are provided to allow fluid communication between the interior of the annular cuff and the interior of the tube 120. The drawing is not to scale, and in general, the axial length of the annular cuff will be less than one quarter of the overall length of the elongated support member 120.

A diaphragm wall 130 closes the other end of the tube 120 and this has a central hole 132.

The illustrated device includes means whereby the cuff can be filled to a predetermined pressure with fluid. These means as illustrated in Figure 1 are constituted by a fluid-filled chamber 134 defined by the diaphragm wall 130, an end closure wall 134, and a cylindrical wall formed by a portion 136 of the elongated support member 120. A portion 138 of this wall is made of a flexible and deformable material, for reasons which will be later understood.

Brackets 140 and 142 are secured respectively to the walls 134 and 130, and serve as the mountings of the two ends of a tension spring 144. In its extended condition as illustrated in Figure 1, the tension spring 144 is exerting a tensional force tending to pull the walls 134 and 130 towards each other. This is prevented by two or more rigid spacer members 146 located on the outside of the tube 120 and bearing against suitable stops. These rigid rods are mounted so that they can readily be manually removed.

As mentioned, there is a central hole 132 in the diaphragm wall 130 and mounted adjacent to this in the main portion of the elongated support member 120 is a non-return valve 150. As indicated by the arrow, this will permit fluid flow in the direction from left to right, that is to say out of the contractible member, but will not permit fluid flow from the interior of the main part of the elongated support member 120 into the contractible chamber.

In use, with the device illustrated in the Figure 1 condition, the annular chamber is collapsed and the device can readily be inserted, for example into the vagina. Thereafter, the spacer rods 146 are removed and the force of the tension spring contracts the contractible chamber 134 and expels a predetermined quantity of fluid from the contractible chamber 134 into the tube 120 and thence through the holes 128 into the annular cuff so expanding it into engagement with the muscle of interest.

According to a further embodiment of the invention, the annular cuff can be filled with pressurised fluid by using a pre-pressurised bulb which is connectible to the interior of an elongated support member. The pressurising fluid may be liquid or gas, and in many instances will be air but liquids, being less compressible than air, are to be preferred.

The illustrated device of Figure 3 has an elongated support member formed by a tube 200, one end 202 being closed and rounded and the other end 204 having inserted therein a plug carrying a pressure transducer. A flexible or stretchable annular wall 206 in combination with a portion 208 of the tube 200 defines an annular cuff, there being fluid communication holes 201 between the interior of the cuff and the interior of the tube 200. The end 204 of the tube constitutes a socket and there is a transverse diaphragm wall 212 which is puncturable by a pointed probe 214 forming part of the pressure transducer in the plug 216. The pressure transducer 216 has a pressure sensitive area 218 which is located in the probe, and senses the pressure of the liquid 220 in the tube 200 and the cuff 206,208.

Initial pressurisation of the cuff 206,208 is achieved by using a prefilled and pre-pressurised bulb of liquid (or gas) the bulb being shown at 224 and having a screw threaded connection with suitable sealing washers, etcetera 226 to a tube 228 leading to the interior of the tube 200. A valve 230 is located in the tube 228 and in normal use, the user will insert the device with the annular cuff in an unextended condition and thereafter open the valve 230 so that the liquid or gas under pressure in the bulb 224 expands into the interior of the tube 200 and to the interior of the cuff 206, 208, so bringing the external wall of the cuff into snug engagement with the muscle whose performance is to be monitored.Fluctuations in pressure achieved by movement of the muscle appear as fluctuations in the pressure of liquid 220, and an electrical signal directly corresponding to said fluctuations appears on electrical leads 234. These may be displayed in any suitable equipment.

It is to be noted that the pressure in the annular cuff will always be the same because it is determined by the fixed quantity of fluid within the device and the volume contraction of the chamber achieved by virtue of the spring 144.

Although not shown in the drawings, a pressure transducer may be located within the liquid in the main portion of the support member 120, in order to give an electrical signal corresponding to changes in the pressure of such liquid, induced by the muscle exercising movement. Reference is made to our co-pending U.K. Patent Application No.

Case 23) for a full description of one suitable arrangement of pressure transducer in combination with a muscle exerciser device.

It will be realised that operation of the device is simplicity itself, and there is no question of any errors or lack of comparability being introduced by the variations from time to time in the pressure to which the annular cuff is filled with inflating fluid. In the Applicants' knowledge and belief, this is a significant advantage over all of the many known prior art constructions discussed or mentioned previously in this Specification.

Claims

1. A device for assisting a person to exercise and improve his or her control of sphincter-type muscles includes an elongated support member which carries or in part defines an annular cuff, the member and the cuff being in communication and filled with a fluid, the cuff being dimensioned and positioned to be capable of sensing small movements of the muscle of interest, and the device also has means whereby the cuff can be filled to a predetermined pressure with fluid.

2. A device according to claim 1 in which the said means consists of a pre-inflated and pre-pressurised bulb or chamber connectible to the interior of the member and hence to the interior of the cuff by a valve located between the bulb and the member.

3. A device according to claim 1 in which the said means consists of a contractible chamber in fluid communication with the interior of the member via a non-return valve, the chamber being associated with a stored-energy means which upon appropriate triggering releases its stored energy so contracting the chamber and urging a portion of the fluid therein into the member and the cuff.

4. A device according to claim 2 or 3 in which the elongated support member has a fluid entry connection by which its interior is directly connected to the pre-inflated bulb or the contractible chamber as the case may be.

5. A device according to claim 3 or 4 in which the contractible chamber is located within an elongated substantially cylindrical support member.

6. A device according to any preceding claim in which the support member is a tube with one closed and one open end, made of latex rubber reinforced over a major part of its length with fibre or cord.

7. A device according to any preceding claim in which the annular cuff is formed by an internal wall constituted by part of the support member and an external wall which is freely stretchable and is of thin latex rubber.

8. A device according to claim 7 in which the inflatable cuff is formed by a hollow annular mem berofsubstantiallytoroidal or "doughnut" shape, having a longitudinal extent of less than a quarter of the length of the elongated support member.

9. A device for assisting a person to exercise and improve his or her control of sphincter-type muscles substantially as herein described with reference to and as illustrated in Figures 1 and 2 of the accompanying drawings.

10. A device for assisting a person to exercise and improve his or her control of sphincter-type muscles substantially as herein described with reference to and as illustrated in Figure 3 of the accompanying drawings.