WO1992020283A1

WO1992020283A1 - A perineometer

Info

Publication number: WO1992020283A1
Application number: PCT/AU1992/000228
Authority: WO
Inventors: William Richards Rayner
Original assignee: Cardio Design Pty Ltd
Priority date: 1991-05-20
Filing date: 1992-05-20
Publication date: 1992-11-26

Abstract

A perineometer comprising an indicating unit (1) and a probe (2). The probe (2) is sized and shaped so as to fit into the vaginal canal of a woman. The probe (2) has a cylindrical flexible cover (22) which fits over and spaced apart from a frame (23). The cover (22) is able to be inwardly radially moved towards the centre resulting in forcing air from the probe (2). The air forced from the probe (2) is relayed by a flexible tube (6) to a diaphragm chamber (7). A diaphragm (8) is thus moved against the action of a spring (9), with a pointer (14) giving an indication of movement in a scale (13). The indication of the scale is non-linear and two ranges are able to be used by the use of a latch (15).

Description

A PERINEOMETER The present invention relates to a perineometer for use by women for exercising the muscles of the pelvic floor.

BACKGROUND OF THE INVENTION During pregnancy and childbirth, the muscles of a woman's vagina are substantially extended and therefore in a period Immediately following birth lack muscle tone. Lack of vaginal muscle tone can lead to Incontinence or partial Incontinence during this period.

It 1s also known that the lack of vaginal muscle tone in older women leads to incontinence or partial Incontinence.

It is well known that, 1n general, muscle tone can be Increased by exercise. However, a difficulty arises in relation to the vaginal muscles 1n that 1t 1s difficult for a woman to know whether her actions are contracting the vaginal muscles. In United States Patent 3,598,106 an intravaginal therapeutic muscle exerciser is described. The exerciser includes a longitudinally extending fluid filled deformable member adapted to be Inserted into the vaginal canal to facilitate voluntary exercise of the muscles of the pelvic floor. The fluid Is connected 1n the device to an external Indicator means to provide visible Indication of muscular constriction. The visual Indicator has a linear response.

In British Patent Application 218959 a simple portable exercising device 1s disclosed for curing female incontinence. The device comprises a fluid filled cylinder which 1s insertable into the vaginal canal. The cylinder is connected by a narrow bore transparent tube to an air filled reservoir. The tube has a scale mounted on 1t, and radial compression of the fluid filled cylinder forces the fluid Into the narrow bore transparent tube which indicates the strength of pelvic floor muscles when certain exercises are performed. Both these commercially available perineometers have certain deficiencies in that a zero datum point is required when using the perineometers. It Is known that the prior art perineometers have inaccuracies due to the variations of the mechanical properties of the probe or other devices. There is also the disadvantage that these perineometers are bench-mounted or require two hands during operation. A perineometer able to be operated by one hand only would be advantageous.

Another disadvantage with the known perineometers is that they have a linear response to the pressure caused by the exercises. Thus 1n order to record initial pressure changes prior to any improvement, with a very long scale must be used or the patient's response after some improvement registers "off-scale". OBJECT OF THE INVENTION

It is an object of the present Invention to provide a perineometer which substantially overcomes or ameliorates the above mentioned disadvantages.

DISCLOSURE OF THE INVENTION According to one aspect of the present Invention there is disclosed a perineometer comprising a hollow probe having flexible side walls, being closed at Its leading end and connected to a flexible tube at the other end, said probe and tube being filled with air and being connected to a pressure transducing means having a variable non-linear response Indicated on a pressure indicating means connected with said transducing means.

BRIEF DESCRIPTION OF THE DRAWINGS Two embodiments of the present invention will now be described with reference to the drawings, 1n which: Fig. 1 Is a longitudinal cross sectional view of a perineometer In accordance with a first embodiment of the present invention;

Fig. 2 is a longitudinal cross sectional view of the probe of the perineometer of Fig. 1,

Fig. 3 1s a front end view of the perineometer of Fig. 1, and Fig. 4 1s a side view of perineometer in accordance with a second embodiment of the present Invention.

BEST MODE OF CARRYING OUT THE INVENTION As seen in Figs. 1 and 2, the perineometer of the first embodiment comprises an indicator unit 1 and a probe 2. The probe 2 is sized and shaped so as to fit into the vaginal canal of a woman. The probe 2 is provided with a closed, dome shaped leading end 21. The probe 2 has a cylindrical flexible cover 22 which fits over a frame 23. The cover 22 is preferably made from a silicone rubber or elastomer. The frame 23 has a idsection 24 where the cover 22 is spaced apart from the frame 23. The cover 22 is able to be inwardly radially moved towards the midsection 24 and in doing so air located between the cover 22 and the midsection 24 is forced through a slot 25 located 1n the tubular midsection 24. The frame 23 of the probe 2 includes an outlet port 3 which is connected to the indicator unit by a flexible tube 6.

The probe 2 and the Indicator unit 1 are connected together by a catch 4. The catch 4 enables the probe 2 and the indicator unit 1 to be clipped together as Illustrated 1n Fig. 1. Within the Indicator unit 1, an Insert 16 1s located at one end of the flexible tube 6. The Insert 16 which has a probe slot 19 fits into the outlet port 3 of the probe 2 with an air-tight seal. The Insert 16 1s located in the flexible tube 6 by means of a protruberence 17 on the insert 16 being captured between a group of four pins 18 which are moulded into the body of the Indicator unit 1. $

The other end of the flexible tube 6 is connected in an air-tight seal to a diaphragm chamber 7 via a Inlet/outlet port 26. Within the diaphragm chamber 7, a flexible diaphragm 8 1s located. The diaphragm 8 1s moved by the air pressure within the diaphragm chamber 7 whereby the movement of the diaphragm 8 Is resisted by a spring 9 which 1s connected to the diaphragm 8 by means of links 10 and 11. Link 11 is able to pivot about a pin 12 and the spring 9 is connected between the link 11 and another pin 27 connected to the body of the Indicator unit 1. Thus for any given pressure applied to the diaphragm chamber 7, the amount of displacement of the diaphragm 8 1s a function of the spring constant of the spring 9 and the active area of the diaphragm 8.

The working length of the spring 9 and hence its spring constant 1s determined by the position of a pivotable latch 15. In one position, the latch allows the full length of the spring line to be utilized. In its second position, the latch 15 immobilizes a portion of the spring therefore Increasing the spring constant of the remaining active portion. Thus the position of the latch 15 changes the reslstence to the displacement of the diaphragm 8. The Indicator unit 1 has on its outside surface a scale 13 along which a pointer 14 Is able to be reciprocally moved. The pointer 14 is fixedly connected to link 10. As the diaphragm 8 is displaced and the links 10 and 11 pivot about pin 12, the pointer 14 moves along the scale 13. The relationship between the reading of pointer 14 to the air pressure in the probe 2 1s determined by the geometry of the linkages 10 and 11 and the pin 12, the spring constant of the spring 9 and the active area of the diaphragm 8. By appropriate variation of these elements, the response of the pointer 14 can be made to suit particular requirements, eg. decreasing rate of response with Increasing pressure.

The scale 13 has a contact 31 which when contacted by the pointer 14 completes an electric circuit having a visual or audible alarm 32 and battery 33. The visual or audible alarm 32 which is connected to the pointer 14 gives an indication to the patient when a preset reading has been attained.

Turning now to Fig. 4, the perineometer of the second embodiment has the Indicator unit 1 connected to the probe 2 by a flexible tube 30. The flexible tube 30 has a cap 31 which clips over the Indicator unit 1 and insert 16 in a similar manner to that of the probe 2 of the first embodiment as previously described. The advantages of the second embodiment 1s that the scale 13 Is more easily observed, especially by pregnant women. However, the apparatus 1s still able to be used one handed.

In use, for either embodiment, the action of connecting the probe 2 to the Indicating unit 7 zeros the reading of the pointer 14 against the scale 13. The probe 2 1s then Inserted Into the vagina. Contractions of the muscles of the pelvic floor of the woman that surround the vagina push air from the probe 2 to the diaphragm chamber 7 in the Indicator unit 1. The diaphragm 8 1s pushed outwardly by the Incoming air. The shape of the diaphragm 8 and the shape of the coacting end of link 10 Is designed so that the active diaphragm area decreases with Increasing stroke, so providing the required reducing indicator response with increasing pressure. Movement of the diaphragm 1s indicated by use of the pointer 14 on the scale 13 which has a non-linear relationship between vaginal pressure and the reading of the scale 13.

The advantages of the above described arrangement are that because of the two operating ranges and the fact that the perineometer has a non-linear response, the perineometer is able to be used for different magnitudes of vaginal muscle contraction. The perineometer is designed for a decreasing rate of response to increasing levels of Input. Consequently, some response on teh more sensitive range is recorded even with very weak muscles. As the patient Improves with exercise the response increases. Then the latch 15 is moved to the less sensitive position and further improvements in response can then be monitored. The act of connecting the probe 2 and the indicator unit 1 automatically establishes the datum or zero point for subsequent readings.

The foregoing describes only two embodiments of the present Invention, and modifications obvious to those skilled in the art can be made thereto without departing from the scope of the present invention.

Claims

1. A perineometer comprising a hollow probe having flexible side walls, being closed at Its leading end and connected to a flexible tube at the other end, said probe and tube being filled with working fluid and being connected to a pressure transducing means, said pressure transducing means connected to a pressure indicating means which indicates a variable non-linear response to pressure applied to said probe.

2. A perineometer according to claim 1 wherein said variable non-linear response provides a decreasing rate of Indicator response to Increasing levels of pressure Input.

3. A perineometer according to claim 1 wherein said pressure transducing means has two separate ranges of non-linear responses.

4. A perineometer according to claim 1 wherein said perineometer Is a one piece apparatus with said hollow probe being detachably connected to a indicating unit which encloses said pressure transducing means and said pressure Indicating means.

5. A perineometer according to claim 1 wherein said transducing means Includes a diaphragm which Is displaced by air pressure, said diaphragm being connected by a link means to a spring means which restricts displacement of said diaphragm.

6. A perineometer according to claim 5 wherein said pressure indicating means 1s connected to said link means to Indicate displacement of said diaphragm.

7. A perineometer according to claim 4 wherein said spring means has a spring constant and said pressure transducing means includes a latch which changes said spring constant to obtain two separate ranges of non-11near responses.

8. A perineometer according to claim 1 wherein said hollow probe has a tubular frame extending partially along its length with a cylindrical flexible cover fitting over said frame, and being spaced apart from said tubular frame which has at least one aperture passing through its cylindrical surface, wherein said flexible cover is able to be Inwardly radially moved to expel air located between said flexible cover and said tubular frame.

9. A perineometer according to claim 8 wherein said probe has an outlet port which is connected with an air-tight seal to said flexible tube.

10. A perineometer according to claim 7 wherein an audible alarm is connected to said pressure indicating means to sound an alarm when a predetermined reading 1s attained.

11. A perineometer according to claim 1 wherein said perineometer 1s zeroed by action of connection said probe to said flexible tube.

12. A perineometer substantially as described with reference to Figs. 1-3 or Fig. 4 of the accompanying drawings.