CA1164746A - Device for assisting control of female incontinence - Google Patents

Abstract

Abstract The device comprises a substantially cylindrical support member which carries or in part defines an inflatable cuff. The cuff extends for only a portion of the length of said support member. Means are provided for inflating the cuff with air and transmitting changes in pressure within the cuff to a display device such as a pressure guage.

Description

~ ~ 64746 --1~

The device of this invention comprises a substantially cylindrical elongated support member which carries or in part defines an inflatable cuff. The cuff extends longitu-dinally less than onc quarter the length ofthe support member. Means are provided for inflating the cuff with a fluid such as a gas, preferably air, and for transmitting changes in pressure in the fluid within the cuff to a display device such as a pressure guage.
The elongated support member also carries a flange optionally adjustable along the length of the member. The elongated member may also have markings or graduations so that the flange position can be noted when the de~ice is first inserted, for example by a .,~ ' '~, ~ 1 ~474~
Xll5 medical practitioner, who will be able to locate the cuff properly in relation to the particular muscle whose tone is to be elevated or improved.
The user is then able to employ the device without the presence of the medical practitioner, having noted the flange position, secure in the knowledge that the muscle of intercst and not an adjacent muscle is being monitored and exercised.
Thus, for a female Datient with urinary incontinence, the flange will be placed in contact with the external surfaces of the labia majora and the member adjusted to correctly locate the cuff relative to the pubococcygus muscle.

Brief Description of the Drawings Fi~ure 1 illustrates one example of a device according to the invention, Figllre 2 illustrates a second example oE a .
device in accordance with the invention, Figure 3 illustrates a third example of a device according to the invention, and ~i~urc 4 illustrates a Eourtll example oE
a device according to the invention.

`~ 1 6A746 'I'his invention relate~s to a device for assis~iny 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 "sphincter-type muscle" is used to mean any internal muscle in the human body which plays a part in controlling the excretory functions. ~xamples are the anal sphincter muscle and the levatores ani group of muscles of the pelvic floor, in particular the pubococcygeus muscle.
Certain conflicting requirements desirably should be met in a device of this kind which is intended for home use by relatively unskilled and non-medical persons. Firstly, the device rnust be stiff enough to insert to the required distance, without it collapsing. Secondly, the dcvice rnust he of a shape and surface texture that is easily and cornfortably inserted. 'l'hirdly, it must be sensitive enou~h to clear]y register musclc movernents on a display unit SUCII as a pressure guaye even though only a very slight muscle movement may have taken place.
The device of this invention by having an inflatable cuff of limited longitudinal (i.e., axial) extent enables the user to monitor a particular selected muscle. The device is very -. . .

~ 1 64746 X~15 sensitive to sliqht muscle movements as a result of the relatively small internal volume of the cuff. Thus small changes in the volume of the cuff register as a si-Jnificant proportional change in the pressure reading on the guage.
According to a particular embodiment of the invention, the device includes a tube with one closed and one open end forming a support member and havlng an inflatable cuff near the closed end a second tube opening into the interior of the inflatable cuff a pressure ~uaqe attached to the other end of the second tube and a va].ve whereby air or gas can be allowed to enter the second tube in order to inflate the cuff. The tube may be made of latex rubber reinforced over a major part of its length with fibre or cord so as to impart the required stiffness to the tube.
In a preferred version of the invention, the inflatable cufe is forrned by an internal wall constituted by part of the support member and an extcrnal wall which is Ereely stretchable.
The stretchable wall rnay be Eormed c~E thin latex rubber. A conduit throu~h whi.cll the cuff is inflated may be formed hy a second tube or by the hollow center of the tube constitutiny the support member.
In an alternative embodiment of the invention the inflatable cuff may be forrned by a hollow annular memher of substantially toroidal or `I ~ 647~6 XF' 1 5 "do~ hnllt" !;l~lpe, '; ~ a].on~ t:h(! ]enyth of the e]onyate~ support member. 'I'lle intcrior of the cuff is then connected to a conduit so that initially the cuff can be inflated and thereafter the changes in internal pressure therein produced by splncter-type muscle movement can be monitored by a pressure gua~Je.
Referring to Figure 1, a rubber tube 10 has reinforcement 12 over most of its length, and has a rounded closed end 14. An inflatable cuff 16 i5 located near t~e end 14 and a second tube 18 is in communication with the interior 17 of the cuff. The tube 18 is connected to a T-piece 20 which is in turn connected to a valve 22 and a pressure guage 24. The tube 10 has a flange 25 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 27 may be marked on the tube 10 so that the user can note the posi-tion of the flange 25 when the cuff 16 is properly located relative to the muscle beiny exercised. The tube 10 is preferably made of latex rubber hy a dipping process and may be amalgamated by this dippiny process with the second and thinner latex tubc 18.
Referring now to rigure 2, the illustrated device includes a first tube 40 and a floppy cuff 4Z. An inflation lumen 48 is provided in~the tube 40 and opens into the interior of 1 J 6~74 6 cuff 42 near its distal er.d. The lumen 48 is directly connected to an external thin tube 50 incorporatin~ a test balloon 52. This gives a visual indication to the user because it is distended when the cuff is inflated. The tube 50 leads to a valve and pressure guage in same way as illustrated in the Figure 1 embodiment.
The tube 40 can be of rubber latex formed by dipping and including a nylon cord reinforcement 41 wound at about 24 turns per 25 mm. of tube length. This reinforcement embedded in the tube wall prevents collapse of the tube 40 during insertion. The floppy cuff 42 can be a thin rubber latex wall and may have an axial length of about 40 ~m. The distal end of cuff 42 may be spaced about 20 mm. from the closed ~istal end 46 of tube 40. The tube 40 may typically have an inner diameter of about 9 mm. and an outer Z0 diameter of about 16 mm., and an overall length of about 220 rnm. The reinforcement 41 may extend over the len~th of tube 40 exccpt for about 10 mm.
at the distal end.
Tuhes 10 and 40 can be made o materials other than rubber. For example, synthetic polymeric materials such as polyvinylchloride or polyurethane with nylon or metal wire reinforcement may be employed.

~ 1 647~6 l'he device i11u~;t,ra~ d in ~i~ure 3 consists of a su~s~,~ntially cylin~rical solid rubber or plastics mandrel 60 with a rounded end 62.
Typically, th~ mandrel may be about 150 rnm. to about 220 mm. in length and of a diameter of about 9 rnm. to about 12 mm. The mandrel 60 carries a sleeve 54 of rubber Ol plastics material which is slidably mounted thereon.
Sleeve 64 has a thin flexible and extensible latex rubber wall 66 fixed to it in an air-tight fashion. Sleeve 64 and wall 66 together define an inflatable cuff to the interior of which is connected a thin-walled tube 68. rrhe tube 68 may be suitably fastened to the mandrel 60, in such a way as to allow slidable movement of the cuff along the mandrel. The tube 68 is connected to a T-piece and valve 70 and then alternatively to a pressure guage 72 or a manually operablé inflater b~lb 74. An advantage of this construction is that the inflatable cuff can readily be moved alony the mandrel 60, nearer to or further from the end 62, as rnay be required to position it appropriately in relation to the muscle whose performance is to be monitored. A
pressure relief valve 76 prevents a pressure greater than a predetermined limit being built up in the cuff 64, 66, even if the bulb 74 is continuously operated.

~ , . . .

~ ~ 647~6 -8- X~15 The device illustrated in Figure 4 includes a hollow rubber latex tube 80 with a rounded end 82, its wall being of appropriate thickness or suitably reinforced (for example as described with reference to the ~evice of Figures 1 and 2) to give the device a stiffness so that it can be readily inserted without discomfort and yet has sufficient rigidity not to be deformed by the muscle movements heing monitored. The tube 80 has a thin flcxible and expansib].e annular rubber latex wall 84, similar to -the wall 16 of Figure 1, defining wit~ the tube 80 an inflatable cuff 86. A hole 88 is provided in the wall of the tube 80 leading into the interior of the annular cuff 86. The interior of the tube 80 is connected by a line 90 to a T-piece and valve, bulb, pressure relief valve and guage (all not shown) in the same way as illustrated in Figure 3.
~lthough n~t shown i.n Figures .~ and 4, a flange corresponding to the flanqe 2S in Fiyure 1, s].idable alonc) the tube, i.s pre~erably include(l in the arranyements shown in [;iyures 3 and 4 Pressure guage 24 (or 72) may be mechan:ical, electrical, or electronic. A muscular contraction will show as an increase in pressure of about 1 to 8 mm. of mercury on the guage, and so will be clearly noticeable to the patient.

~ ~ 64746 _g_ The pressure guaye may be an elec-tronic pressure sensor unit capable of giving either a numerical display of pressure value or a display of lights, for example of different colors, triggered by the achievement of certain pressure valves. For example, with such a unit it could be arranyed usin~ suitahle circuity that a given muscle contraction (and hence a given pressure) illuminates a lamp of one color, a greater contraction illuminates a lamp of a second color, and a greater contraction still illuminates a lamp of a third color. Such a unit would preferably include a means of controlling the sensitivity so that the particular levels of pressure at which given lamps are illustrated could be adjusted.
For improved sensitivity, it is preferred that tube 18 or tubes 50 and 48 or tube 68 be thin. For example, the tube may have an inner diamctcr of about 0.5 to about 1.5 mm.
The devices of this invention are employed as follows. Tlle device is inserted into the body ori~ice to the desired depth as dctermined by flan~e 25. The valve 22 or 72 is opened and the cuff is inflated in any convenient way to a light pressure, for example about 40 to 60 mm. of mercury. The valve is closed and the patient then attempts to contract the sphincter muscles. The resultant efforts show cl~arly on the pressure guage.

Claims (7)

The embodiments of the invention m which an exclusive property or privilege is claimed are defined as follows:-

1. A device for assisting a person to exercise and improve control of sphincter type muscles comprising a substantially cylindrical elongated support member wherein said support member is a tube with a closed rounded distal end which carries or in part defines an inflatable cuff having a longitudinal extent which is less than one quarter of that of said support member wherein said cuff is located near said rounded distal end wherein a second tube opens into the interior of said cuff, the other end of said second tube is attached to a pressure guage, and a valve whereby air or gas can be allowed to enter said second tube and inflate said cuff, a flange serving as a location device and adjustable along the length of said support member and said support member includes a series of graduations or markings, and means for transmitting changes in pressure in the fluid within said cuff to a display device.

2. A device according to Claim 1 wherein said support member is formed of rubber latex which is reinforced over a major portion of its length.

3. A device according to Claim 1 in which the reinforcement is nylon cord wound at 24 turns per 25 millimeters of tube length.

4. A device according to Claim 1 in which said support member is amalgamated with said second tube by a latex dipping operation.

5. A device according to Claim 1 in which said inflatable cuff is formed by an internal wall constituted by part of said support member and an external wall which is freely stretchable.

6. A device according to Claim 1 wherein said support member is formed of rubber latex which is reinforced over a major portion of its length and the external stretchable wall of said cuff is formed of thin latex rubber.

7. A device according to Claim 1 in which the inflatable cuff is formed by a hollow annular member of substantially toroidal shape, said cuff is slidable along the length of said elongated support member, and a thin tube connects to said cuff to means for inflating said cuff with air or gas.