Apparatus for treating pelvic floor dysfunctions using transcutaneous electrical stimulation of the muscles

A device adapted to be worn by a human to provide transcutaneous neural stimulation or EMG monitoring useful for treating pelvic floor dysfunctions which includes a base portion comprising a flexible, nonabsorbent material layer configured to overlie the pelvic floor region of a human. The base is provided with an opening or slot disposed to overlie the anus or the vagina of the wearer to aid in proper positioning of the device. A pair of electrodes are mounted to the base in spaced relationship to one another and in surrounding and closely adjacent relationship to said slot. The electrodes preferably have a configuration adapted to overlie a sufficient portion of the pelvic floor region surrounding the anus of the wearer to effect a highly efficient stimulation of the pelvic floor muscles. Preferably, the base portion is securely held in position by a plurality of strap portions connected to the base which extend upwardly from the rear and front of the wearer for releasable connection to a holding member secured to or near the waist of the wearer.

FIELD OF THE INVENTION 
The present invention relates generally to treating pelvic floor 
dysfunction including urinary, fecal or associated disorders and 
particularly to a wearable device which includes electrodes which are 
accurately positioned in electrical contact with the skin surface about 
the pelvic floor area of the wearer to more advantageously provide for 
electrical stimulation and electromyography (hereinafter EMG) measurements 
related to specific muscles involved in treating pelvic floor 
dysfunctions. 
BACKGROUND AND DESCRIPTION OF RELATED ART 
Pelvic floor dysfunctions, such as urinary incontinence, for example, is a 
common problem in a large percentage of adults. Studies have shown that 
this problem can be effectively treated in a large percentage of the 
cases, however, various forms of urinary incontinence or other pelvic 
floor muscular dysfunctions require different forms of treatment or 
combinations thereof to increase the rate of success. 
It has long been known that muscles can be electrically stimulated by the 
application of electrical impulses to the surface of the skin, referred to 
as transcutaneous electrical stimulation. For useful results, the proper 
positioning of the electrodes in relation to the nerve and associated 
muscle to be stimulated is very important. 
Studies have been conducted using patch type surface electrodes which are 
adhesively attached to the body in the area of the pelvic floor for 
electrical stimulation of the pelvic floor muscles involved in treating 
urinary incontinence. The results of this study indicate such treatments 
can be useful to increase the success rate of combating urinary 
incontinence. In addition EMG measurements are desirable to monitor the 
course of progress during treatment. 
However, the drawbacks to the prior method and means of treatment include 
significant irritation of the patient's skin, the need of relatively 
highly trained personnel to properly position the electrodes and/or 
properly instruct patients to position the electrodes and the fact that 
the configuration and nature of the patch type electrodes used, which are 
commercially widely available for general use, are not wholly satisfactory 
to provide efficient and effective treatment of the area involved. 
Skin irritation of the patient from the adhesively applied electrode 
patches interferes with the treatment regimen required to effectively and 
comfortably treat a patient. In order to effectively treat a patient for 
these types of disorders, it is necessary to repeat the treatment several 
times over a significant number of days. In at least some instances, it is 
desirable to employ a continuous treatment over an interval of several 
hours in a day, which must also be repeated on subsequent days. The fact 
that many medical personnel have little or no training regarding the 
accurate positioning of the electrodes for treating pelvic floor 
dysfunctions, or for EMG monitoring, has limited the effective use of the 
prior method and means to a limited number of medical facilities which 
have a properly trained staff. 
The above noted drawbacks have so limited the use of electrical stimulation 
techniques for treating these disorders that it is essentially not 
available to most of the patient population who may benefit from this form 
of treatment. Additionally, these drawbacks represent disincentives to the 
patient such that it is very difficult to obtain the patient cooperation 
necessary to conduct the full course of treatment required to be 
successful in resolving the problem. 
There are presently available garments which carry a plurality of 
electrodes for electrical stimulation of different areas of the body, 
however, these garments are limited to generally large and more readily 
accessible areas of the body and are not suitable for use in treating 
pelvic floor dysfunctions, such as urinary incontinence. Such prior art is 
represented by U.S. Pat. No. 4,919,148 and the patents cited therein, for 
example. 
SUMMARY OF THE INVENTION 
The present invention relates to a wearable device for providing electrical 
stimulation and EMG monitoring of the muscles of the pelvic floor useful 
to treat pelvic floor dysfunctions. The device consists of a supporting 
base portion comprising, preferably, a tight knit material which is 
configured to overlie the pelvic floor muscles of the wearer. A pair of 
electrodes are mounted on the base in closely spaced but separated 
relationship and are configured to overlie a major area of the pelvic 
floor surrounding the anus of the wearer to assure effective contact with 
the nerves which control the pelvic floor muscles of interest. 
An open space, preferably configured as a narrow slot, is provided in the 
base portion. One function of this slot is to prevent undesired electrical 
contact between the closely spaced electrodes or the conductive gel 
associated with an absorbent layer overlying each electrode. Further the 
slot represents an electrode positioning aid or guide when, preferably, it 
is disposed directly over the anus of the wearer to assure the base 
portion is properly positioned to dispose the electrodes in electrical 
contact with the area of the skin related to stimulating the desired 
muscles. In females, the slot may alternatively be positioned over the 
vaginal opening instead of the anal opening. Additionally, the slot 
provides access to the technical clinician to palpate the anal or vaginal 
passage, as applicable, of the wearer to ascertain the level of muscle 
contractions imparted by a given level of current being applied. 
The supporting base preferably includes a pair of straps extending in 
opposing directions outwardly from the base which are adapted to be 
attached to a waist belt, or the like, releasably mounted on the wearer to 
secure the supporting base and the electrodes in an operative position. 
This combination forms an effective harness to not only carry the 
operative electrodes, but a convenient and easy to use means to adjustably 
position the electrodes in their proper location in a consistent manner. 
In one preferred embodiment, each electrode is disposed in a respective one 
of a pair of pockets formed on the base in spaced relationship to one 
another. Each pocket includes an outer side comprising an absorbent 
material which may be readily wetted by a conventional conductive gel to 
increase the effectiveness of transmitting the desired electrical signals 
and to control contact of the gel to the desired limited area of skin. 
Therefore it is an object of the present invention to provide a device of 
the type described to provide improved electrical stimulation and/or EMG 
monitoring of the pelvic floor muscles to enhance treatment of pelvic 
floor dysfunctions. 
It is another object of the present invention to provide a device of the 
type described which is easily positioned upon the body of the wearer to 
accurately and consistently dispose the electrodes in contact with the 
desired body area and which requires very little medical education or 
training to do so. 
It is another object of the present invention to provide a device of the 
type described which may be worn by the user during normal activity and 
still maintain the desired positioning of the electrodes in overlying 
contact with the area being treated. Therefore several daily repetitive 
treatments or a continuous extended daily treatment over several hours is 
made highly practical and more convenient for the patient. 
It is a further object of the present invention to provide a device of the 
type described which accurately secures the position of the electrodes for 
electrical stimulation and/or EMG measurements in a difficult access 
region of the body in a relatively comfortable manner to encourage user 
compliance with the regimen of treatments necessary to aid in resolving 
the urinary incontinence problem.

In describing the preferred embodiment of the invention which is 
illustrated in the drawings, specific terminology will be resorted to for 
the sake of clarity. However, it is not intended that the invention be 
limited to the specific terms so selected and it is to be understood that 
each specific term includes all technical equivalents which operate in a 
similar manner to accomplish a similar purpose. For example, the word 
"connected" or terms similar thereto are often used. They are not limited 
to direct connection but include connection through other mechanical means 
or electrical circuit elements where such connection is recognized as 
being equivalent by those skilled in the art. 
BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENT 
It is to be understood that the term pelvic floor dysfunctions includes 
urinary incontinence, fecal and other associated disorders involving the 
muscles of the pelvic floor region. As described below herein, the 
preferred embodiment is described in connection with treating urinary 
incontinence, as an example, however treating other forms of pelvic floor 
dysfunctions using the apparatus described will be apparent to those 
skilled in the art. 
Also, reference to the pelvic floor muscles as used herein is meant to 
include the anal sphincter muscles and the urethral sphincter muscles, as 
well as the pelvic muscles which support the bladder and urethra. 
Strengthening the latter muscle group is considered particularly important 
in many causes of urinary incontinence problems. 
FIGS. 1, 5 and 6 show a wearable device, indicated generally at 10, for 
treating urinary incontinence using electrical stimulation and/or EMG 
measurements which is constructed in accordance with the present 
invention. 
The device includes an electrode supporting base area 12 configured to 
overlie the pelvic floor region of the wearer and is preferably made from 
a layer of flexible, non-conductive and generally non-absorbent material. 
A tight knit woven fabric material which is stretchable works well for 
purposes of the present invention. A blend of nylon and polyester, such as 
sold under the SPANDEX trademark, is quite suitable, although other types 
of materials would be expected to work well. 
A pair of electrodes 14 are mounted to base 12 in closely spaced 
relationship to one another and each are covered by a layer of an 
absorbent material, such as felt layer 16, which readily absorbs liquid 
and can be thoroughly wetted by a conventional conductive fluid or gel. A 
suitable gel for purposes of the present invention is available under the 
trademark SIGNAGEL electrode gel, however, other appropriate conductive 
mediums, including solid forms under development or other types of 
conductive fluids, may also be used without departing from the spirit of 
the present invention. The electrodes 14 may be retained to base 12 by any 
conventional means which provides the necessary stability and the desired 
electrical contact with the targeted skin area via any suitable conductive 
medium. 
The felt layer 16 preferably is sewn or otherwise securely fixed about its 
outer edges to the underlying material layer of base 12 to form a pocket 
or pocket-like structure preferably having a shape generally similar to 
the configuration of each electrode 14 which is disposed within a 
respective one of the pockets. The absorbent layer 16 is referred to as 
the outer side of the pocket and the underlying material of base 12 forms 
the inner side. 
The felt layer is preferred because it can absorb a sufficient amount of 
the conductive fluid to provide good electrical contact between the skin 
and the electrode. Further, it tends to confine the conductive fluid to 
the area represented by the dimensions of the felt layer so reasonable 
control of the area of electrical contact between the skin and the 
electrode is maintained while wearing the device. Other forms of pockets 
or other configurations to operatively mount electrodes 14 on base 12 may 
also be used effectively to accomplish the desired result. 
Each electrode 14 may be of any conventional conductive material and 
preferably is made in a relatively flexible form. Such materials are 
well-known to those skilled in this art. Also each electrode 14 is 
configured to efficiently cover the surface area necessary to effectively 
stimulate the muscles of the pelvic floor area to be treated. One highly 
preferred configuration is a generally L-shape, such as shown in FIGS. 1 
and 4, wherein each electrode is disposed in overlying and surrounding 
relationship to an opening or slot 18 provided in base 12. 
Since the proper positioning of the electrodes relative to contact with the 
desired area of skin is very important for electrical stimulation 
treatment as well as obtaining accurate EMG monitoring, slot 18 performs 
an important alignment function as described in detail later herein. 
Further, slot 18 allows closely adjacent spacing of the confronting edges 
of felt coverings 16 overlying each electrode 14 in order to maximize the 
area of electrical contact in the desired area, yet it provides an 
insulating space or barrier to prevent undesired electrical contact 
between the wetted felt coverings 16 which could short out the electrodes. 
The guide or alignment function of slot 18 which facilitates the proper 
positioning of electrodes 14 in overlying relationship to the desired area 
of the pelvic floor of the wearer renders the device very user friendly. 
One simply aligns slot 18 over one of the predetermined body cavities 
comprising either the anus or the vagina, where applicable. Then, by 
adjusting the attachment of straps 20 and 22 to a holder, such as waist 
belt 24, at an appropriate length, the desired positioning of the 
electrodes 14 and felt pads 16 is maintained. Aligning slot 18 in 
overlying relationship to one of the above-mentioned pre-selected body 
cavities, assures correct positioning has been made and/or is being 
maintained during the treatment interval. The dotted circle 19, in FIGS. 
2-4 diagrammatically illustrates the anus of the wearer relative to a 
desired position of slot 18. 
Providing a guide means, such as slot 18, in combination with the manner in 
which base 12 is secured in position, greatly increases the effectiveness 
of treatment. Further proper positioning assures that the device is more 
comfortable to wear. These features reduce the need for a high degree of 
education or training regarding this form of treatment by medical 
personnel aiding the patient. With minimal instructions, a lay person, 
including the user would be able to correctly mount the device in the 
proper position. 
This aspect of convenient and facile positioning and comfortable 
wearability offers greatly expanded opportunity for use and successful 
treatment of urinary incontinence or other pelvic floor dysfunctions using 
electrical stimulation compared to the prior methods and means. In 
addition, the relative comfort provided to the wearer is very important to 
encourage cooperation of the patient in properly conducting the regimen of 
treatments for successful re-training of the muscles involved in the 
particular pelvic floor dysfunction involved. 
Further, slot 18 provides convenient access for palpation of either the 
vaginal passage or anal passage, according to the design of the apparatus, 
for clinical confirmation of the appropriate functional level of muscular 
contraction being effected by a given level of current application to the 
electrodes. Appropriate adjustment of the level of electrical current 
applied can then be assured in a simple manner. However, it is recommended 
that EMG monitoring also should be used at appropriate intervals to more 
precisely measure the functional level of muscular contraction being 
effected by the level of electrical stimulation being applied. 
Now referring to FIGS. 1, 5 and 6, base 12 includes front and rear elongate 
strap portions 20 and 22 respectively, each of which is preferably formed 
into two separate legs, such as "A" and "B". Straps 20 and 22 are adapted 
to reach upwardly from the wearers crouch area to make a releasably fixed 
connection to a support or holding member, such as belt portion 24, which 
is secured around the waist of the wearer. Each leg "A" and "B" of straps 
20 and 22 preferably diverge from one another for attachment in spaced 
relationship about the circumference of belt 24 to better secure and 
stabilize the position of base 12 and hence, electrodes 14, in the desired 
position relative to the wearer's body and form an effective wearable 
harness-like structure to hold electrodes 14 in the desired position. 
Belt 24 is preferably made of an elastic material which can be snugly and 
securely held in position around the waist of the wearer. Complementing 
VELCRO attaching means, such as indicated at 26, are preferably used to 
releasably tighten belt 24 in a secure position on the wearer and to 
secure the strap portions "A" and "B" to belt 24. However, other suitable 
well-known releasable attaching means can be used without departing from 
the spirit of the present invention. Such means preferably provide for 
easily adjusting the effective length of the strap portions to permit the 
base 12 to be held snugly against the wearer to accommodate persons of 
varying size. The elastic or resilient nature of the material used for 
base 12 and, if desired, strap portions 20 and 22, may also aid in 
adapting the device to comfortably and properly fit persons of different 
statures and sizes. 
Further, a pair of suspenders or the like, not shown, could be used with or 
without belt 24 in order to support the desired position of strap portions 
20 and 22 and thus base portion 12. 
Now referring specifically to FIGS. 3 and 4, two modified electrode 
configurations are illustrated for use in the device of the present 
invention. In FIG. 5, the modified configuration of electrodes 14a 
comprises a pair of generally triangular shapes which are tilted or offset 
relative to a line longitudinally directed through slot 18 so as to 
overlie a substantial area to each side, above, below and closely adjacent 
to the anus of the wearer. 
If desired, it should be understood that for females, slot 18 could be 
designed to be aligned over the vaginal opening, instead of the anus, with 
an appropriate re-positioning and or selection of the shape of the 
electrodes 14 and pockets 16 to accommodate this change of position to 
obtain effective coverage of the pelvic floor area. This modification 
would provide the same effect of assuring correct alignment of electrodes 
14 over the desired pelvic floor area and also permit access to palpate 
the vaginal passage to check the level of muscular contractions being 
affected. 
With reference to FIG. 4, a pair of generally semi-circular shaped 
electrodes 14b are shown which are configured to overlie a major portion 
of skin area of the pelvic floor area surrounding the anus of the wearer. 
It is noted that a generally U-shape or horseshoe shape as well as 
confronting C-shapes for electrodes 14 and felt coverings 16 could also be 
effectively used in a similar fashion to the semi-circular shape shown in 
FIG. 4 to obtain a desirable amount of surface contact with the desired 
area in this body region. Also such shapes could be easily rotated 90 
degrees from that shown in FIG. 6 to accommodate positioning slot 18 over 
the vagina of a female user. 
In the same manner for all the embodiments shown, a conventional wire 30 
may be attached to each electrode 14 and extended outwardly from the 
pocket formed between felt coverings 16 and the underlying material of 
base portion 12. The outer end of each wire 30 may be provided with a 
female receptacle 32 for a conventional pin connector to conveniently 
connect a respective electrode to a source of electrical stimulation or to 
other electronically operated measuring and recording devices, such as for 
EMG monitoring, for example. The means for providing and operating such 
electrical sources are conventional and well-known, therefore they need 
not be shown or described in detail for one of ordinary skill in the art 
to understand how to make and use the present invention for its intended 
purpose. 
In view of the foregoing description, it should be understood that the 
device described provides a convenient and an easy to use means for 
transcutaneous electrical muscle stimulation and/or EMG monitoring of the 
muscles of the pelvic floor region for treating pelvic floor dysfunctions, 
including urinary incontinence. It provides a vast improvement to the 
adhesively applied electrodes and allows secure, accurate and consistent 
placement of the electrodes in this difficult to access region of the 
body. It should be pointed out that consistent placement is important to 
both stimulation of the proper muscles and particularly to EMG monitoring. 
The present invention also provides a relatively high degree of comfort 
and reduces the inconvenience to the patient undergoing such treatment. 
Further, it solves the problem of interruptions of treatments due to 
patient skin irritation caused by prior methods and means which also 
increases the tendency of patients to refuse to continue treatment. 
Additionally the present invention allows the patient a high degree of 
normal activity while wearing the device so as to reduce the inconvenience 
of a daily treatment regimen. 
Slot 18 provides a means for facile and accurate alignment of the base 12 
to assure accurate positioning of electrodes 14 by personnel lacking 
extensive education and training in this form of treatment and provides 
access to the pre-selected body cavity for palpation by a trained 
clinician. From the foregoing description it should be understood that the 
present invention promotes more widespread access to such treatment 
compared to prior methods and means. 
It should also be pointed out that an electrical stimulation regimen and 
EMG monitoring may be combined with other forms of treating behavioral 
aspects of urinary incontinence. Such other forms include pelvic floor 
exercises as prescribed by a knowledgeable physician or therapist. Such a 
combination is believed to maximize the success rate of overcoming many of 
the major causes of urinary incontinence or other pelvic floor 
dysfunctions, excepting of course, those due to non-reversible causes. 
While certain preferred embodiments of the present invention have been 
disclosed in detail, it is to be understood that various modifications may 
be adopted without departing from the spirit of the invention or scope of 
the following claims.