Device for devloping control of spincter-type muscles

[54] DEVICE FOR DEVLOPING CONTROL OF SPINCTER-TYPE MUSCLES

[75] Inventor: Howard V. Matthews, Sussex, England

[73] Assignee: E. R. Squibb & Sons, Inc., Princeton, N.J.

[21] Appl. No.: 256,416

[22] Filed: Apr. 22,1981

[30] Foreign Application Priority Data

May 20, 1980 [GB] United Kingdom 8016613

[51] Int CI.4 A61M 25/00

[52] U.S. CI 128/774; 604/96;

604/99; 604/100

[58] Field of Search 128/774-780,

128/348-350, 748; 604/96-100

[56] References Cited

U.S. PATENT DOCUMENTS

2,458,305 1/1949 Sanders 128/348

2,507,858 5/1950 Kegel 128/2

2,541,520 2/1951 Kegel 128/2

2,638,093 5/1953 Kulick 128/133

3,502,328 3/1970 Hamilton 272/80

3,598,106 8/1971 Buning 128/2

3,646,929 3/1972 Bonnar 128/1

3,726,273 4/1973 Cole 128/2

3,752,150 8/1973 Harris 128/2

3,926,178 12/1975 Feldzamen 128/2

4,048,985 9/1977 Sasse 128/2

4,050,449 9/1977 Castellana et al 128/2

4,133,303 1/1979 Patel 128/774

4,149,539 4/1979 Cianci 128/350 R

4,167,938 9/1979 Remih 128/778

4,216,783 8/1980 Kaiser et al 128/778

4,230,102 10/1980 Ekbladh 128/349 R

4,325,387 4/1982 Heifer 128/778

FOREIGN PATENT DOCUMENTS

790091 11/1935 France 128/780

81-02098 8/1981 PCT Int'l Appl 128/774

808867 2/1959 United Kingdom .

1303559 1/1973 United Kingdom .

1399093 6/1975 United Kingdom .

1511557 5/1978 United Kingdom .

1547328 6/1979 United Kingdom .

2047539 12/1980 United Kingdom .

OTHER PUBLICATIONS

Kegel, "Physiologic Therapy for Stress Incontinence",
JAMA, vol. 146, 915-917, (1951).
Jones, "Nonoperative Treatment of Stress Inconti-
nence", Clin. Obstet. & Gynec, vol. 6, 220-235 (1965).

Primary Examiner—Nancy A. B. Swisher
Attorney, Agent, or Firm—Lawrence S. LeVinson;
Stephen B. Davis

[57] 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 gauge.

3 Claims, 2 Drawing Sheets

DEVICE FOR DEVLOPING CONTROL OF
SPINCTER-TYPE MUSCLES

BACKGROUND OF THE INVENTION

Devices have been proposed for exercising sphinctertype muscles. For example, Kegel in U.S. Pat. Nos. 2,507,858 and 2,541,520 employs a device having a core and a laterally extending vulcanized 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 to bring its wall into engagement with the wall of the muscle of interest. A pressure guage 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 it is not popular among users because it is uncomfortable to insert and to use and the results obtained often are not sufficiently specific to a particular muscle of interest.

Other devices for exercising sphincter-type muscles are disclosed by Hamilton in U.S. Pat. No. 3,502,328, by Buning in U.S. Pat. No. 3,598,106, by Cole in U.S. Pat. No. 3,726,273, by Harris in U.S. Pat. No. 3,752,150, by Feldzamen in U.S. Pat. No. 3,926,178, by Sasse in U.S. Pat. No. 4,048,985, by Castellana et al. in U.S. Pat. No. 4,050,449, by Remich in U.S. Pat. No. 4,167,938, by Kaiser et al. in U.S. Pat. No. 4,216,783 and by Sokol in British Pat. No. 808,867.

SUMMARY OF THE INVENTION

The device of this invention comprises a substantially cylindrical elongated support member which carries or in part defines an inflatable cuff. The cuff extends longitudinally less than one quarter the length of the 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 device is first inserted, for example by a 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 interest and not an adjacent muscle is being monitored and exercised.

Thus, for a female patient 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

FIG. 1 illustrates one example of a device according to the invention,

FIG. 2 illustrates a second example of a device in accordance with the invention,

FIG. 3 illustrates a third example of a device according to the invention, and

FIG. 4 illustrates a fourth example of a device according to the invention.

2

DETAILED DESCRIPTION OF THE
INVENTION

This invention relates to a device for assisting a per'son 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. Examples 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 must be stiff enough to insert to the required distance, without it collapsing. Secondly, the device must be of a shape and surface texture that is easily and comfortably inserted. Thirdly, it must be sensitive enough to clearly register muscle movements on a display unit such as a pressure guage 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 sensitive to slight 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 significant 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 having an inflatable cuff near the closed end, a second tube opening into the interior of the inflatable cuff, a pressure guage attached to the other end of the second tube, and a valve 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 cuff is formed by an internal wall constituted by part of the support member and an external wall which is freely stretchable. The stretchable wall may be formed of thin latex rubber. A conduit through which the cuff is inflated may be formed by a second tube or by the hollow center of the tube constituting the support member.

In an alternative embodiment of the invention, the inflatable cuff may be formed by a hollow annular member of substantially toroidal or "doughnut" shape, slidable along the length of the elongated support member. The interior 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 spincter-type muscle movement can be monitored by a pressure guage.

Referring to FIG. 1, a rubber tube 10 has reinforcement 12 over most of its length, and has a rounded closed end 14. An inflatable cuff 16 is located near the 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