U.S. patent number 3,926,178 [Application Number 05/541,830] was granted by the patent office on 1975-12-16 for apparatus for aiding the voluntary exercising of sphincter muscles.
Invention is credited to Alvin N. Feldzamen.
United States Patent |
3,926,178 |
Feldzamen |
December 16, 1975 |
Apparatus for aiding the voluntary exercising of sphincter
muscles
Abstract
A device for aiding the exercising of sphincter muscles
comprising an insertable member, means disposed around the
insertable member yieldable in response to muscle action, and an
indicator responsive to the yieldable member is disclosed. The
yieldable member comprises independent sets of tubing wrapped
around the core of the insertable member and actuated in response
to the contractions and relaxations of different sphincter muscles
to indicate their functioning and the comparative strengths between
muscles.
Inventors: |
Feldzamen; Alvin N. (Annapolis,
MD) |
Family
ID: |
24161252 |
Appl.
No.: |
05/541,830 |
Filed: |
January 17, 1975 |
Current U.S.
Class: |
600/591;
600/38 |
Current CPC
Class: |
A61B
5/4337 (20130101); A63B 23/20 (20130101); A61B
5/202 (20130101); A61H 21/00 (20130101); A61B
5/42 (20130101); A63B 21/008 (20130101); A63B
2220/56 (20130101) |
Current International
Class: |
A61H
21/00 (20060101); A61B 5/03 (20060101); A63B
23/00 (20060101); A63B 23/20 (20060101); A63B
21/008 (20060101); A61B 005/00 () |
Field of
Search: |
;128/2S,64,303.12,79,344,67,24.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Trapp; Lawrence W.
Attorney, Agent or Firm: Sughrue, Rothwell, Mion, Zinn &
Macpeak
Claims
What is claimed is:
1. An apparatus to aid the voluntary exercising of muscles
comprising:
a member adapted to be inserted into a sphincter muscle cavity,
said member having a rigid core;
a plurality of flexible tubes forming helices disposed around the
core, said tubing yieldable to the contractive forces exercised by
the sphincter muscles; and
means connected to said flexible tubing to indicate the degree of
effort intended to exercise the muscles against helices and the
rapidity by which the muscles can be contracted and relaxed.
2. The apparatus of claim 1, wherein, said rigid core has a rounded
head at one end thereof, a tapered section around which said tubing
is wound to form a series of helices, a flange to limit insertion
disposed at the end of said tapered section and a handle to
facilitate insertion at the opposite end thereof.
3. The apparatus of claim 2, where said member has a sheath
covering said rounded head, said helices and said flange, the
sheath being held in place by two bands located on each side of the
flange.
4. The apparatus of claim 3, wherein said helices are maintained at
atmospheric pressure and said indicating means is a pressure gauge
to measure the changes in pressure when said muscles are exerted
and relaxed.
5. The apparatus of claim 4 wherein said helices are selectably
coupled to said pressure gauge.
6. The apparatus of claim 1 wherein said helices are maintained at
atmospheric pressure and said indicating means comprises a set of
liquid level or displacement gauges, each gauge independently
coupled to one tube to indicate which muscles are being exercised,
the comparative strength of said muscles, the rapidity of
contraction and relations of said muscles, and the sequence of
muscular activity.
7. The apparatus of claim 1 wherein said helices are maintained at
atmospheric pressure and said indicative means comprises a set of
Bourdon tubes, each Bourdon tube independently coupled to one tube
to indicate which muscles are being exercised, the comparative
strength of said muscles, the rapidity of contraction and relation
of said muscles, and the sequence of muscular activity.
8. The apparatus of claim 1 where said plurality of flexible tubing
comprises, a first tube having a sealed end and wrapped around said
rigid core forming a series of helices over a length of said core
and then disposed inside said core for the remaining length of said
member and a second tube having a sealed end and wrapped around
said core, starting at the location where said first tube is
disposed inside said core and forming a second set of helices over
a second length of said core and then disposed into said core for
the remaining length of said member.
9. The apparatus of claim 1 including coupling means disposed
between said tubing and said indicator means.
10. The apparatus of claim 1 wherein said rigid core is hollowed
plastic and provided with an end cap.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to the field of exercising devices for
developing, regenerating, or reconstructing sphincter muscles.
2. Prior Art
In the prior art a variety of techniques and structures is known
for exercising and treating sphincter muscles. In broad terms, the
prior art is replete with many devices such as shown in U.S. Pat.
Nos. 1,216,183, 1,584,464, 1,729,044 and 2,263,219 which teach the
application of heat, chemically or electrically, via elongated
tubes to massage and treat injured internal muscles. Other devices
such as in U.S. Pat. No. 1,327,786 describe apparatus for the
introduction of medicines and the application of a vibrator to the
elongated tube for vibratory treatment of injured muscles or to
enhance their development. Other devices may apply electrical
currents to stimulate muscular contractions.
While many of these prior art devices are useful in the treatment
of injured tissue, their use as exercise aids or devices is
limited. In essence, the lack of these devices to provide an
indication of the measure of progress during voluntarily controlled
exercise or to indicate a baseline upon which improvement can be
premised limit their usefulness as practical exercise aid
equipment. Two patents to Kegel, U.S. Pat. Nos. 2,507,858 and
2,541,520 disclose basic apparatus for the indication of
progressive voluntary exercise of sphincter muscles. In U.S. Pat.
No. 2,507,858 an insertable member 1 having a core 2 and outside
sheath 10 is employed with an air space 13 maintained at
atmospheric pressure. Connected to the member 1 by tubing 14 is a
simple pressure sensitive gauge 15. A base flange 7 limits the
degree of insertion and the squeezing of muscles against the sheath
10 causes a reduction in the volume of space 13 thereby generating
a pressure in the closed system measured by the gauge 15. The
device was considered to be an improvement over the earlier filed
Kegel U.S. Pat. No. 2,541,520 which employed a bulb 4 to pressurize
the tube 2 and probe 1 to a positive pressure against which the
injured muscles reacted. The U.S. Pat. No. 2,507,858 indicated that
the use of atmospheric pressure provided a standardized minimum
resistance to simplify exercise and instructions.
SUMMARY OF THE INVENTION
This invention relates to a method of and apparatus for aiding the
voluntary exercising, and indicating the progressive degrees of
voluntary exercising, of sphincter muscles either singly or, where
appropriate, sets of muscles at the same time. Sphincters are
generally defined as ring-like muscles surrounding and able to
contract or close a natural opening. In humans and particularly in
the vaginal anatomy of females, two major groups of sphincter
muscles are present. The first and most external or distal pair of
muscles are the bulbocavernosus and (the second muscle controlling
the outer vaginal area) the urethral spincter muscle. The second
major group of muscles of the levatur ani group contain the
pubococcyaeus, iliococcygeus, and puborectalis, located at the
deeper portions of the organ.
In the embryologic development of the muscles it is known that the
muscle cell first develops alone and then later receives a nerve
supply. Accordingly, a muscle cell which has lost its innervation
through inactivation or injury may become reinnervated under
certain conditions, typically defined as occurring when there is a
physiological demand for muscle cell reinnervation to control such
function and, as in the embryologic state, the nerve fibril reaches
out to make contact with the injured muscle cell.
A common cause of injury of sphincter muscles in women is during
childbirth although trauma can also occur by exercise or bruising.
The muscle injury itself often consists of the separation of the
nerve fibril from the muscle cell but the nerve fibril will
generally reconnect quickly upon use of the muscle. If, however,
the muscle is not used, there is no need for the nerve to reconnect
and the striated muscle fibers with their many nuclei will atrophy
when this nerve supply is lost. Restoration of the tonus of the
muscle is possible if it is reinnervated and in these muscles the
motor axons are capable of branching to innervate a much larger
mass of muscle fiber than normal.
It has long been known that the voluntary exercise of several of
the specified sphincter muscles aids the control of bladder
incontinence, the control of the lower bowel and, hence, also helps
overcome fecal incontenence and involuntary flatulence.
The need for voluntary exercise of these muscles is then desirable
to prepare for childbirth and to aid in the recovery therefrom, to
improve the sensations during copulation, and for bladder and bowel
control. Because these muscles are generally thought of as being
semi-involuntary in nature, exercise is a difficult task requiring
concentration unless some means of indicating the degree of
utilization is provided as a feedback mechanism.
Additionally, in many situations, muscles are injured so severely
that they are practically useless and a device utilized in the
rehabilitation of them must be extremely sensitive. The process of
voluntary exercise, whether for regeneration or reconstruction of
injured muscles, or development of under-utilized muscles, requires
a degree of awareness on the part of the individual as to progress,
or indeed, whether the exercise is even taking place. In the case
of sphincter muscles the function is rarely perceived even under
normal conditions and the problem of making the individual
cognizant of the extent of injury or progress is more difficult.
Accordingly, an effective means of indicating the extent of muscle
use is crucial. Additionally, the process of voluntary exercise
involves repetition and in the case of muscle development where
slight variations may be indicative of large orders of magnitude of
improvement, any device must be reliable and consistent in
measurement.
These general criteria are carried out in the present invention
where an insertable member is utilized having groupings of
convoluting tubes each responsive to the functioning of a different
set of sphincter muscles. Each grouping of tubes may be used
separately to stress the exercise of an individual set of muscles,
or together to exercise all at the same time. The ability to
discern which, in a series of muscles, is being exercised is an
important improvement over the prior art. In many cases, the
muscles being close together, would, in the case of the Kegel
devices, indicate positive readings or improvement, where in
actuality a damaged or weakened muscle is not being developed but
the indications being the result of flexing or contracting an
adjacent muscle. For women with groups of muscles in the vaginal
area, dystrophy of some muscles may not be readily apparent and it
is desirable to discern healthy from weak muscles.
Additionally, the Kegel devices use a prestressed yieldable
diaphragm with the attendant problems of holding the diaphragm in
place with an air tight fitting around the flange. The problem of
air leakage in the diaphragm in Kegel is recognized and solved by
the use of an adaptor; however, maintaining the proper pressure
requires relatively expensive fittings and this device due to high
cost has not achieved widespread acceptance or recognition in the
medical profession.
Accordingly, it is an object of this invention to provide an
inexpensive yet reliable device to aid the voluntary exercise of
sphincter muscles.
Another object of this invention is to provide a method and
apparatus by which an individual becomes aware of the functioning
and degree of strength of the sphincter muscles.
It is yet another object of this invention to provide apparatus by
which an individual can voluntarily exercise sphincter muscles for
their development, reconstruction, or regeneration.
It is still a further object of this invention to provide an
apparatus having a member insertable in a sphincter muscle which
comprises a spine or core, a plurality of helicies around the core,
each helix yieldable against the muscle being exerted, and an
indicator associated with the helicies to indicate the degree and
the rapidity of muscle action.
These and other objects and advantages of this invention will be
apparent from the following detailed description of a preferred
embodiment thereof as illustrated in the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1a is a diagrammatic illustration of the insertable member
embodying this invention;
FIGS. 1b-d are schematic views of various types of indicators used
with the FIG. 1a probe; and
FIG. 2 is a sectional view of the insertable element.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
In the apparatus comprising this invention there is generally
provided in FIG. 1a an insertable member 10 which is adapted to be
inserted into the lumen surrounded by sphincter muscles, so that
the muscles may be urged against it. The insertable member has a
rounded head 12 with a tapered section 14 and having bands 16 and
20 to hold sheathing, to be described later, in place, a flange or
ring 18 and end fitting 22 with cap 24.
As shown in greater detail in FIG. 2, the insertable member 10 has
a core 26 with a rounded tip 28. The flange or ring 18 and the end
fitting 22 can typically with the core 26 be fashioned in one piece
either out of plastic by a suitable process such as injection
molding, hard rubber, or metal, such as aluminum. As shown, this
member is hollow but has sufficient wall thickness to maintain
rigidity. Wrapped around the core 26 are a series of helicies of
thin plastic tubing 30, 32. As shown the helix 30 starts with a
sealed end abutting against a wall of the core 26, and is tightly
wound for about one half of the length of member 10, where it then
goes through the wall at point 34 and proceeds inside the body of
the device until reaching the end cap 24 where it exits. At the
point 34, where tube 30 disappears into the body of the insertable
member, a second plastic tube 32 is wound around the hollow core 26
forming a second helix with a sealed end located in proximity to
the location where the first tube goes inside the core. Whether the
second helix has its sealed end inside or outside the hollow core
26 is not crucial so long as the discontinuity in the helicies is
minimized, that is, it is more important to maintain a packed
series of coils. The second helix is wrapped around the core, the
remaining length of the insertable member and then, in a manner
similar to the first tube,, passes inside the hollow core at
position 38 near the flange 18. The tube then passes through the
inside of the end fitting 22 exiting at the cap 24.
It is evident that the two helices 30 and 32 operate independently
of each other along different sections of the insertable member.
This facilitates reaction to, and the indication of, the
functioning of different muscles closely situated near each other.
Because these muscles may be of differing potential strengths the
tubing may be of varying size, composition or wall thickness to
accommodate these differences. It must, however, be sufficiently
sturdy to withstand crushing but of a flexibility to be sensitive
to slight muscle contractions. Also, although two separate helices
are shown, it is evident that one or an increased number of
separate loops may be used.
Covering the helices is a sheathing material 40 which is stretched
over the head 28, coils 30, 32 and flange 18. The sheathing,
preferably thin plastic or rubber, is held in place by bands l6 and
20, which may be rubber bands or thin plastic or metal clamps. The
unit as assembled is typically about 5-7 inches long and tapering
from about 1 inch diameter at the base of the flange to 0.75 inches
diameter at the head 12, with the insertable portion about 3.5
inches long.
An end cap 24 seals off the end fitting 22 which also serves as a
handle for the device with the flange or ring 18 limiting insertion
of the device. The tubes 30 and 32 upon exiting from the insertable
member are coupled to an indicator. As shown in FIG. 1a and FIG. 2
couplings 42, 44 are provided to link tubes 30, 32 to extensions
46, 48; however, in some uses the tubing can be continuous from the
member 10 directly to the indicator. The use of couplings does
serve as a convenience to connect the pressure indicator or to
restore atmospheric pressure into the tubes, if needed.
FIGS. 1b, 1c and 1d show three different types of sensitive
indicators which can be used. Because the device operates at
atmospheric pressure the particular sensor is not critical and the
three shown in the drawing are only illustrative of a variety of
known alternatives. FIG. 1b shows the tubes 46, 48 coupled to a
pair of Bourdon tubes 50, 52 mounted on stand 54. The Bourdon tube
indicates pressure differentials by straightening out a flat
section and suitable indicator means (not shown) may be used. For
phychological reasons an indicator such as this may be desirable in
addition to its low cost.
A second alternative is shown in FIG. 1c where the tubes 46, 48 are
connected to liquid level pressure sensors 56, 58, which causes the
levels of liquid to rise and fall in columns 60, 62 in response to
variations in pressure. Suitable indicia 61 can be employed to
measure relative results. With liquid level devices, floats or
various fluids can be employed. A less complex embodiment may use
simple narrow bare transparent tubes, portions of which are filled
with a colored liquid, whose motions may be observed.
A third alternative is shown in FIG. 1d where the tubes 46 and 48
are joined at point 66 into one tube 68 which is coupled to a
conventional pressure sensitive gauge 70. Only one gauge is shown
because this instrument is generally more expensive than the other
types, however, it is obvious that the coupling at 66 can be
eliminated and two gauges used, one for each tube. If a single
gauge is used, clamps 72, 74 may be provided to effectively
disconnect one tube from the gauge if reading from only one set of
coils is desired.
In operation, the member 10 is inserted into the sphincter muscles
and by varying the exercise routine, measurements can be observed
as a result of interaction of the muscles on either coils 30 or 32.
As the individual becomes aware of the voluntary control
exercisable over the muscles, manifested by initial pressure
readings and their variations, repeated effort will cause the
muscles to strengthen to the point where increased readings are
obtained indicating improved voluntary muscular contractions, and
the readings varying with conscious control and attaining a
rapidity of contraction and relaxation, the individual will have
been "taught" to utilize these semi-voluntary muscles.
Also, because, as noted above, the muscles are often found in
adjacent pairs, it is possible by this invention to determine which
muscles are strong or weak by comparison to adjacent muscles and
then to emphasize the voluntary exercise of the weaker muscles.
Using both sets of helicies it is possible to train the voluntary
contractions of these muscles to be either together or in sequence,
and to be contracted and relaxed voluntarily with rapidity.
It is apparent from the above description of the present invention
that various adaptations, modifications and substitutions can be
presented therefor without departing from its spirit and it is
intended that the present invention be limited only by the
hereinafter appended claims.
* * * * *