|Publication number||US3926178 A|
|Publication date||Dec 16, 1975|
|Filing date||Jan 17, 1975|
|Priority date||Jan 17, 1975|
|Publication number||US 3926178 A, US 3926178A, US-A-3926178, US3926178 A, US3926178A|
|Inventors||Alvin N Feldzamen|
|Original Assignee||Alvin N Feldzamen|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (5), Referenced by (44), Classifications (18)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent 1191 Feldzamen Dec. 16, 1975 APPARATUS FOR AIDING THE VOLUNTARY EXERCISING OF SPHINCTER MUSCLES  Inventor: Alvin N. Feldzamen, 5 5 East St.,
Annapolis, Md. 21401  Filed: Jan. 17, 1975 [211 App]. No.: 541,830
 US. Cl 128/2 S; 128/79  Int. C1. A61B 5/00  Field of Search 128/2 S, 64, 303.12, 79,
 References Cited UNITED STATES PATENTS 12/1940 Stanzel l28/24.1 5/1950 Kegel 128/2 s 2/1951 Kegel 128/2 S 4/1973 Cole 128/2 5 8/1973 Harris 128/2 S Primary Examiner Lawrence W. Trapp Attorney, Agent, or FirmSughrue, Rothwell, Mion, Zinn & Macpeak 57 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.
10 Claims, 5 Drawing Figures US. Patent Dec. 16, 1975 3,926,178
APPARATUS FOR AIDING THE VOLUNTARY EXERCISING OF SPHINCTER MUSCLES 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 US. 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 US. 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, US. Pat. Nos. 2,507,858 and 2,541,520 disclose basic apparatus for the indication of progressive voluntary exercise of sphincter muscles. In US. Pat. No. 2,507,858 an insertable member 1 having a core 2 and outside sheath 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 US. 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 US. 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 1 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 bulbocavemosus 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 semiinvoluntary in nature, exercise is a difficult task req uiring concentration unless some means of indicating the degree of utilization is provided as a feedback mecha nism.
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 p1ace..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 weak- 3 ened 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. la is a diagrammatic illustration of the insertable member embodying this invention;
FIGS. lb-d are schematic views of various types of indicators used with the FIG. la 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 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 ho]- low 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 16 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. lb, 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 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. I
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
6 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.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US2225240 *||Apr 12, 1937||Dec 17, 1940||Stanzel George A||Hydrotherapeutic massage bar|
|US2507858 *||Apr 29, 1948||May 16, 1950||Arnold H Kegel||Apparatus to indicate progressive exercise of injured sphincter muscles|
|US2541520 *||Jan 13, 1947||Feb 13, 1951||Arnold H Kegel||Method and apparatus for indicate or observe progressive exercise of injured sphincter muscles|
|US3726273 *||Jul 21, 1971||Apr 10, 1973||N Cole||Muscle exercising device|
|US3752150 *||Aug 30, 1971||Aug 14, 1973||J Harris||Exercising apparatus|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US4241912 *||Jan 29, 1979||Dec 30, 1980||Mercer Jean H||Isometric vaginal exercise device and method|
|US4776347 *||Apr 22, 1981||Oct 11, 1988||E. R. Squibb & Sons, Inc.||Device for devloping control of spincter-type muscles|
|US4785828 *||Oct 6, 1986||Nov 22, 1988||Empi, Inc.||Vaginal stimulator for controlling urinary incontinence in women|
|US4873996 *||Aug 18, 1988||Oct 17, 1989||Empi, Inc.||Vaginal stimulator for controlling urinary incontinence in women|
|US4881526 *||May 27, 1988||Nov 21, 1989||Empi, Inc.||Intravaginal electrode and stimulation system for controlling female urinary incontinence|
|US4953563 *||Jun 20, 1986||Sep 4, 1990||Howard Kaiser||Protective disposable sheath for muscle monitor|
|US5010895 *||Aug 3, 1989||Apr 30, 1991||Empi, Inc.||Expandable vaginal electrode|
|US5674238 *||Jun 24, 1996||Oct 7, 1997||Research Foundation Of The State Univ. Of N.Y.||Perineometer|
|US5865715 *||Jan 20, 1998||Feb 2, 1999||Wallick; H. David||Contraction resistance vaginal muscle exerciser|
|US6059717 *||Aug 3, 1998||May 9, 2000||Dabney; J. Conway||Sexual aid|
|US6063045 *||Jan 14, 1998||May 16, 2000||Deschutes Medical Products, Inc.||Pubococcygeal training biofeedback device|
|US6258015 *||Oct 25, 2000||Jul 10, 2001||Richard Blackford||Exercise device|
|US6354991||Oct 6, 1999||Mar 12, 2002||Bio Control Medical Ltd||Incontinence treatment device|
|US6652449||Oct 5, 1999||Nov 25, 2003||Bio Control Medical, Ltd.||Control of urge incontinence|
|US6712772||Feb 15, 2002||Mar 30, 2004||Biocontrol Medical Ltd.||Low power consumption implantable pressure sensor|
|US6862480||Nov 29, 2001||Mar 1, 2005||Biocontrol Medical Ltd.||Pelvic disorder treatment device|
|US6896651||Jan 15, 2002||May 24, 2005||Biocontrol Medical Ltd.||Mechanical and electrical sensing for incontinence treatment|
|US7387603||Nov 30, 2004||Jun 17, 2008||Ams Research Corporation||Incontinence treatment device|
|US7582053||Sep 24, 2003||Sep 1, 2009||Ams Research Corporation||Control of urge incontinence|
|US7613516||Nov 28, 2002||Nov 3, 2009||Ams Research Corporation||Pelvic disorder treatment device|
|US8083663||Jun 17, 2009||Dec 27, 2011||Ams Research Corporation||Pelvic disorder treatment|
|US8160710||Jul 10, 2007||Apr 17, 2012||Ams Research Corporation||Systems and methods for implanting tissue stimulation electrodes in the pelvic region|
|US8195296||May 5, 2006||Jun 5, 2012||Ams Research Corporation||Apparatus for treating stress and urge incontinence|
|US8340786||Jun 12, 2008||Dec 25, 2012||Ams Research Corporation||Incontinence treatment device|
|US8380312||Dec 30, 2010||Feb 19, 2013||Ams Research Corporation||Multi-zone stimulation implant system and method|
|US8774942||Mar 27, 2012||Jul 8, 2014||Ams Research Corporation||Tissue anchor|
|US9220887||Jun 7, 2012||Dec 29, 2015||Astora Women's Health LLC||Electrode lead including a deployable tissue anchor|
|US9427573||Jun 23, 2011||Aug 30, 2016||Astora Women's Health, Llc||Deployable electrode lead anchor|
|US9539433||Mar 18, 2009||Jan 10, 2017||Astora Women's Health, Llc||Electrode implantation in a pelvic floor muscular structure|
|US9731112||Aug 28, 2012||Aug 15, 2017||Paul J. Gindele||Implantable electrode assembly|
|US20030082884 *||Oct 26, 2001||May 1, 2003||International Business Machine Corporation And Kabushiki Kaisha Toshiba||Method of forming low-leakage dielectric layer|
|US20050049648 *||Oct 12, 2004||Mar 3, 2005||Biocontrol Medical Ltd.||Pelvic disorder treatment device|
|US20050113881 *||Nov 30, 2004||May 26, 2005||Yossi Gross||Incontinence treatment device|
|US20050130818 *||Apr 22, 2003||Jun 16, 2005||Karol Mihal J.||Pelvic floor muscle exercisers and indicators|
|US20050216069 *||Nov 28, 2002||Sep 29, 2005||Biocontrol Medical Ltd.||Pelvic disorder treatment device|
|US20050261746 *||Sep 24, 2003||Nov 24, 2005||Yossi Gross||Control of urge incontinence|
|US20070265675 *||May 9, 2007||Nov 15, 2007||Ams Research Corporation||Testing Efficacy of Therapeutic Mechanical or Electrical Nerve or Muscle Stimulation|
|US20080009914 *||Jul 10, 2007||Jan 10, 2008||Ams Research Corporation||Systems and Methods for Implanting Tissue Stimulation Electrodes in the Pelvic Region|
|US20080242918 *||Jun 12, 2008||Oct 2, 2008||Ams Research Corporation||Incontinence Treatment Device|
|US20090012592 *||Jul 10, 2008||Jan 8, 2009||Ams Research Corporation||Tissue anchor|
|US20090157091 *||Jan 3, 2007||Jun 18, 2009||Ams Research Corporation||Apparatus for Implanting Neural Stimulation Leads|
|US20100049289 *||Sep 11, 2009||Feb 25, 2010||Ams Research Corporation||Tissue anchor|
|US20100076254 *||Jun 5, 2007||Mar 25, 2010||Ams Research Corporation||Electrical muscle stimulation to treat fecal incontinence and/or pelvic prolapse|
|US20110160793 *||Dec 30, 2010||Jun 30, 2011||Ams Research Corporation||Multi-Zone Stimulation Implant System and Method|
|U.S. Classification||600/591, 600/38|
|International Classification||A61H21/00, A61B5/03, A63B23/20, A63B21/008|
|Cooperative Classification||A61H21/00, A61B5/202, A61B5/4337, A63B23/20, A61B5/42, A63B2220/56, A63B21/008|
|European Classification||A61B5/20D, A61B5/42, A61B5/43F3F, A63B23/20, A61H21/00|