APPARATUS AND METHOD FOR TESTING AND EXERCISING PELVIC MUSCLES

Abstract: An apparatus (70) for testing and/or strengthening pelvic floor muscles includes an external casing (72) having two separate (74, 76) pieces threaded or snap fit together, and a set of inserts (86) having different weights (15) being individually positioned in the external casing (75).

Description: APPARATUS AND METHOD FOR TESTING AND EXERCISING PELVIC MUSCLES BACKGROUND OF THE INVENTION The present invention relates to a pelvic muscle testing and/or strengthening apparatus and method for testing and/or strengthening pelvic muscles. More particularly, the present invention relates to an adjustable weight pelvic muscle testing and/or exercising apparatus and method of using same. Exercises for the perineal muscles, also referred to as pelvic floor muscles, are often prescribed by physicians for various reasons including strengthening the pelvic muscles which assist in the control of urinary incontinence or stress incontinence. Stress incontinence results in urine leakage during physical stress. Physical stress can occur when physically exerting oneself such as when lifting or moving heavy objects. However, such stress can also occur when coughing, sneezing, etc. Indeed, occasionally stress incontinence can result when simply standing up. Stress incontinence is typically caused by a weakening of the pelvic muscles. This might be due to the normal aging process or child bearing. Stress incontinence can be treated by exercising the pelvic muscles. However, it is often difficult to teach proper exercising of the pelvic muscles during a brief office visit. Moreover, it is often difficult to obtain and insure patient compliance with an exercise regimen because women have difficulty in exercising the proper muscles. Oftentimes, women contract the wrong muscle group such as the abdominal muscles. In addition, there is often no specific feedback providing the person with information on how strong the pelvic muscles are or the amount of force which is being applied by the pelvic muscles. Expensive and time consuming biofeedback devices have been developed in an effort to overcome some of these problems and provide more reliable exercising of the pelvic muscles. These devices typically include a probe which is inserted into the vagina. The vaginal probe is electrically connected to an external control device. Pressure on the probe is transduced into electrical signals and transmitted to the control device. The signals are then converted into a discernable output, e.g., visual or audio; by the control device to provide patient feedback on the changes in vaginal pressure being detected by the probe. The problem with such devices is that they are relatively expensive and time consuming. Typically the patient must be at a health care facility in order to use such devices which is very inconvenient. In order to overcome the above noted problems with the biofeedback devices, various mechanical devices have been developed which are configured for insertion into the vagina. Upon insertion, the pelvic muscles grip the device thereby exercising the pelvic muscles. Through repeated use over a period of time, the pelvic muscles are thus strengthened. Examples of such devices are disclosed in U.S. Patent Nos. 2,763,265, 4,241,912 and 4,895,363 and UK Patent Application no. GB 2058571A. U.S. Patent No. 2,763,265 discloses a device for exercising the pelvic muscles which is contoured and proportioned with multiple protuberant zones for exercising the pelvic muscles in sequence as the device is introduced into the vagina. UK Patent Application No. G 2058571 A describes a device for exercising the perineal muscles. The device includes a shaft having a tapered portion with an enlarged spherical end for insertion in the vagina. The device includes an eyelet at the other end of the device such that various weights can be suspended from the end of the device. U.S. Patent No. 4,241,912 describes an isometric vaginal exercise device including a rounded shaft having a flange attached to one end thereof. The shaft has a concave portion adjacent the flange, wherein the diameter of the concave portion decreases to a minimum value and then increases to a maximum value with increasing distance from the flange along the shaft . Upon insertion into the vagina, the concave portion is gripped by the paravaginal muscles of the user. The flange has an oval shape to permit accommodation between the legs of the user. A handle is attached to the flange end of the device. U.S. Patent No. 4,895,363 discloses a set of devices of identical size and shape, but of different weight. One of the devices is inserted into the vagina, and if the pelvic muscles are capable of retaining that weight, the device is replaced by a heavier device of the set. The heaviest device that can be retained is a measure of a pelvic floor muscle strength, and the muscles can be exercised by retaining the device for a predetermined time, such as fifteen to twenty minutes per day. While the aforementioned devices are cheaper and more practical than the use of typical biofeedback devices, they nevertheless have various undesired characteristics associated therewith. For example UK Patent Application GB 2058571 A is rather cumbersome to use in that it requires the use of hanging weights. U.S. Patent Nos. 2,763,265 and 4,241,912 do not allow use of varying weights. U.S. Patent No. 4,895,363 uses a plurality of devices which are all of identical size and shape. Many users require different sizes of devices in order to provide a better fit for the exercise device. These are but some of the undesirable features associated with the prior art. The present invention provides an improved apparatus and method for testing and/or exercising pelvic muscles which offers many advantages over existing devices. SUMM7ARY OF THE INVENTION The present invention relates to a pelvic floor muscle testing and/or strengthening device. One embodiment of the pelvic floor muscle testing and/or strengthening device generally in accordance with the principles of the present invention includes an external casing and a plurality of inserts being respectively positioned into the external casing. In one embodiment, the multiple external hollow casings of varying external size are provided so as to provide a better individualized fit. In one embodiment, the multiple casings all have the same sized cavity. A plurality of the inserts are provided of the same external size but varying weight. The inserts are configured and sized for placement in the cavity of the casings. Once an individual has selected an external casing which best fits them, they can vary the weight of the exercise device by choosing one of the inserts. In one embodiment of the present invention, the device has an external "tampon like" geometric contour for easy vaginal insertion, fit and removal. The external casing is made of a bio-compatible material which can be cleaned and sterilized. In one embodiment of the present invention, a replaceable cord for removing the device from a body cavity is fastened to the external casing. The cord is made of a soft pliable threading or plastic material. In one embodiment, an exercise kit is provided wherein there are multiple hollow casings of varying external sizes and a plurality of inserts having different weights positionable in the hollow casing. The present invention in one embodiment pertains to a method of testing and/or exercising pelvic muscles comprising the step of selecting an insert from a plurality of inserts of differing weights and inserting the insert in a hollow casing. The casing with the insert is then inserted into the vagina. In one embodiment, when testing the strength of the pelvic muscles, the weight of the casing/insert combination is gradually increased until the device is no longer supported in the vagina. This provides an indication of the strength of the pelvic muscles. In one embodiment, when exercising the pelvic muscles, a casing/insert combination is retained in the vagina for a period of time. This is periodically repeated so as to gradually strengthen the pelvic muscles. These and various other advantages and features of novelty, which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for a better understanding of the invention, its advantages and objects obtained by its use, reference should be had to the drawings which form a further part hereof, and to the accompanying descriptive matter, in which there is illustrated and described a preferred embodiment of the invention. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, in which like reference numerals and letters indicate corresponding parts throughout the several views: FIG. 1 is an exploded cross-sectional view of a pelvic floor muscle testing and/or strengthening device in accordance with the present invention; FIG. 2 is a cross-sectional view of the pelvic floor muscle testing and/or strengthening device; FIG. 3 is a cross-sectional view of the pelvic floor muscle testing and/or strengthening device having a narrower insert; FIG. 4 is a cross-sectional view of the pelvic floor muscle testing and/or strengthening device having a shortened insert; FIG. 5 is a cross-sectional view of the pelvic floor muscle testing and/or strengthening device having a hollowed insert; FIG. 6 is a cross-sectional view of the pelvic floor muscle testing and/or strengthening device having a hollowed and shortened insert; FIG. 7 illustrates a set of hollow casings and inserts which might be included in an exercising kit in accordance with the principles of the present invention; FIG. 8 illustrates another embodiment of the inserts in accordance with the principles of the present invention,* FIGS. 9A, 9B illustrate yet another embodiment of the inserts in accordance with the principles of the present invention; FIG. 10 illustrates yet another embodiment of the invention wherein the inserts are integrally molded as a part of the casing top piece; FIG. 11 illustrates in cross section yet another embodiment of the invention having a plurality of distinct inserts disposed in the casing; and FIG. 12 is an exploded cross sectional view of the embodiment of FIG 11. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT In FIG 1, there is shown an embodiment of a pelvic floor muscle testing and/or strengthening device in accordance with the principles of the invention (hereinafter called "device") which is designated by the reference number 70. The device 70 has an external two piece casing 72 including a top piece 74 and a bottom piece 76 which defines a hollow inner chamber or cavity 75. An inner threaded wall portion 78 of the top piece 74 is threadedly engaged with an outer threaded wall portion 80 of the bottom piece 76 so that the hollow inner chamber 75 is defined by the top and bottom pieces 74,76 threadedly attached to one another. The top and bottom pieces 74,76 can be repeatedly attached and detached by simply threading and unthreading them. It will be appreciated that the top and bottom pieces 74, 76 might be removably attached by other methods; e.g., they might be snap fitted together. The casing 72 has a "tampon like" geometric contour wherein the top piece 74 has a curved end 82, and the bottom piece 76 has a narrower cone shaped end portion 84. Thus, the device 70 can be easily inserted into the vaginal cavity of the user (not shown) . It will be appreciated that the casing 72 might have other configurations and yet be in keeping with the principles of the invention. The material of the external casing 72 is a bio- inert material, such as polystyrene plastic, that is able to be easily cleaned and sanitized. The casing pieces 74 and 76 might be made in any suitable manner. For example, they might be injection molded or machined out. Preferably the casings 74 and 76 have a minimum wall thickness of .039 inches. An insert 86 is positionable in the hollow inner chamber 75. The insert 86 has a head portion 88 contoured to abut or be in close proximity with an inner wall 90 of the top piece 74 and a body portion 92 contoured to abut or be in close proximity with at least a portion of an inner wall 94 of the bottom piece 76. The insert 86 further includes a shoulder portion 96 between the head portion 88 and the body portion 92 which circumferentially surrounds the insert 86. As shown in FIG. 2, upon being positioned in the casing 72, the shoulder portion 96 engages an end 97 of the bottom piece 76 so as to support the insert 86 in the casing 72, the head portion 88 being disposed in a cavity in the top piece 74 of the casing 72 and the body portion 92 being disposed in a cavity in the bottom piece 76. In the preferred embodiment of the invention a plurality of the inserts 86 having a different weight are used with the casing 72 to provide a pelvic muscle exercise and/or test device whose weight can be varied by simply selecting one of the inserts 86 and placing the insert in the casing 72. In a preferred embodiment a plurality of the casings 72 are also provided. The casings 72 preferably define a cavity of the same size and configuration but have different external sizes. Accordingly, the present invention allows the individualization of the exercise device in that an appropriate sized casing can be selected by the user. The weight of the inserts 86 is made different by changing the size and/or configuration of the inserts and/or making the inserts from materials of different densities. In the preferred embodiment, the configuration of the inserts is changed by varying the configuration of the body portion 92 and/or the head portion 88. This can best be illustrated by looking at FIGS. 2-6. The body portion 92 can be narrowed to achieve a lesser weight as shown in FIG.3. The body portion 92 can be shortened to achieve a lesser weight as shown in FIG.4. The body portion 92 and/or the head portion 8.8 can be hollow to achieve a lesser weight as shown in FIG.5. The body portion 92 and the head portion 88 might be both hollow and the body portion 92 shortened as shown in FIG.6. It is appreciated that there are various ways in keeping with the principles of the invention of varying the configuration of the insert 86 so as to vary the weight of the insert 86. In other embodiments the head portion of the inserts 86 might be changed to vary the configuration of the inserts 86 and thus their weight. However, in the preferred embodiment the inserts 86 maintain their symmetrical design about their longitudinal axis. In addition, the shoulder portion 96 maintains the same diameter in the preferred embodiment. As previously noted, another method of varying the weight of the insert 86 is to use materials of different densities. In the preferred embodiment, the material of the insert 86 would include aluminum, brass, bronze, stainless steel, molybdenum, manganese, titanium, lead, zinc or other alloys. The inserts 86 might be made by any suitable method. For example, they might be machined or cast. They might also be swaged or made from an alternative method such as compressed powdered metal. The inserts 86 preferably are coated with an acrylic material so that the inserts can be easily cleaned and to prevent the insert material, such as lead, from rubbing off. The weight of the inserts 86 might range from 5 to 100 grams. Illustrated in FIG. 7 is a collection of the inserts 86 of different weight and the casings 72 of different external size in accordance with the principles of the present invention. The inserts 86 and the casings 72 might be packaged together as a kit providing an exercise device which can be individualized according to the user's needs. The inserts 86 and casings 72 might be suitably marked with indicia so as to allow the user to identify their relative weights and/or sizes. For example the inserts 86, they might be color coded and/or bear indicia indicating their weight. In the embodiment shown, the five inserts might have the following weights 15, 27.5, 40, 52.5, 65 grams. In one embodiment, the casings 72 have a length of approximately five (5) cm and a diameter of two (2) cm tapering down to about one (1) cm on the small end. The casings 72 are preferably free of cracks, burrs, gouges, embedded foreign material, smudges or contaminants. In one embodiment, the casings 72 weigh five (5) grams. It will be appreciated that varying numbers, sizes and/or configurations of the casings 72 and the inserts 86 might be utilized in keeping with the principles of the invention. Illustrated in Figure 8 is yet another embodiment of the invention, wherein the inserts 86 are molded about a sub-insert 87 of varying size and/or configuration. This provides for a set of inserts having varying weights. In the embodiment shown, the inserts 86 all have the same external configuration. The inserts 86 might be molded of polystyrene and include suitable indicia or other markings reflecting their weight. For example, a suitable identification might be molded right into the polystyrene. The sub- inserts 87 might be made of metal or any other suitable material. The sub-inserts 87 might all be made of the same material or different material so as to provide the appropriate weight differential between inserts 86. The inserts 86 would preferably be insertable in a casing 72 as discussed previously Shown in Figures 9A,B is yet another embodiment of the present invention. In this embodiment, the inserts 86 are composed of multiple parts, preferably two parts 86a and 86b. In Figure 9A, the parts 86a,b are separated along an axis extending longitudinally of the insert 86 and in Figure 9B, the parts 86a,b are separated along an axis extending transversely of the insert 86. By varying the sizes and/or configurations and/or densities of the parts, the total weight of the inserts 86 can be changed. Thus a kit comprising a collection of the parts 86a,b can be utilized to create inserts of varying weight simply by interchanging one or more of the parts 86a,b. As discussed above, the inserts 86 are preferably insertable in a casing 72. Shown in Figure 10 is yet another embodiment of the present invention. In this embodiment inserts 86a-e are integrally molded with the casing top piece 74a-e. The inserts 86a-e each have a different weight so as to provide the insert device 70 with a different weight simply by attaching one of the top pieces 74a-e to the bottom piece 76. The top pieces 74a-e might be suitably marked with appropriate indicia to indicate their absolute or relative weight. For example, in the embodiment shown, the inserts 86a-e each have a different configuration at their distal ends. The lightest of the inserts 86a-e has a more pointed distal end. It will be appreciated that the different top pieces 74a-e with their inserts 86a-e might be identified in any number of ways. Also, although in the embodiment shown it is intended that the top pieces 74a- e are threadedly attachable to the bottom piece 76, it will be appreciated that the top and bottom pieces might be removably attachable to one another in a variety of ways, including but not limited to a bayonet type attachment, a snap type attachment, etc. Shown in Figures 11 and 12 is yet another embodiment. In this embodiment, the device 70' has a two piece casing 72' with a top piece 74' and a bottom piece 76' which threadedly attach to each other. The top piece 74' has a shaft portion 74'a, threaded along its distal end 74'b, which is threadedly receivable in a threaded aperture 76'a disposed in the bottom piece 76' . A plurality of identical tungsten inserts 86', suitably plated with chrome or other material, are slidably receivable on the shaft portion 74'a. It will be appreciated that any number of the inserts 86' or none of the inserts 86' might be used so as to allow the weight of the device 70' to be varied simply by adding or deleting inserts 86' as needed on the shaft portion 74'a and then threading the top piece 74' and the bottom piece 76' together. The inserts 86' are shown as having a disc shape with an aperture in the center. The top piece 74' and the bottom piece 76' have cavities which cooperate to define one cavity or inner chamber 75' for receiving the inserts 86' . Integrally molded with the bottom piece 76' is an elongated member 102' such as a string or the like. It will be appreciated that the elongated member 102' might be attached in various ways and yet be in keeping with the principles of the invention. For example, as with the previous embodiments, an aperature might be molded in the bottom piece 76' for receipt of an elongated member. This embodiment might be sold as a kit containing the top piece 74', the bottom piece 76' and a plurality of the inserts 86' . In one embodiment of the kit there might be six of the inserts 86' however a varying number of inserts might be present. In a preferred embodiment, the inserts 86' are of identical size, configuration and weight. In yet other embodiments the inserts 86' might vary in weight, size and/or configuration. The present invention also provides an exercise device with an apparatus for removal of the exercise device from the body cavity. In the preferred embodiment shown, an opening 100 is disposed in the cone shaped end 84. A cord 102 is knotted or has a fastener 104 at one end so as to be retained in the cone shaped end 84. The cord 102 extends through the opening 100 to the outside of the casing 72. Thus, the user is able to pull on the cord 102 to remove the device 70 out of the body cavity. In the preferred embodiment, the cord 102 is able to withstand 2.25 lbs. of separating force without breaking. The cord 102 might be made of various materials such as nylon monofilament thread or other suitable soft pliable threading. In the preferred embodiment, the cord 102 has a diameter of 0.020 inches. It will be appreciated that other methods and or structures might be provided to facilitate removal from the body cavity. In use, a user first chooses one of the external casings 72 of suitable size. The external casing 72 can be used alone without any inserts if so desired. To increase the weight of the device an insert 86 is added into the hollow inner chamber 75. If the weight of the insert 86 is not great enough or is too much, then the insert 86 is replaced by an another insert 86 having a greater weight or lesser weight as desired. In the preferred embodiment this is done by simply unthreading the top and bottom pieces of the casing 72, removing an insert and replacing it with another one. The top and bottom pieces of the casing 72 are then threaded back together. After each use, the user should wash the casing 72 with soap and water, rinse, dry and place in a suitable storage compartment. It will be appreciated that it may not be necessary to wash the inserts 86 after each use as they do not come in contact with the body. When used as an exercise device, the user might exercise 10 to 20 minutes once or twice a day for a couple of weeks until the muscles are sufficiently strengthened. After that the user might not do any further exercising or might exercise but a few times a week. When a device of the proper weight is placed in the vagina, it has a tendency to slip out. In response to this sensation, the pelvic muscles contract around the device to retain the device in the body cavity. The user might keep a written record of their exercise progress which provides additional feedback to the user as the user can readily ascertain their progress over a period of time and see their improvement. When used as a test device, the user would keep increasing the weight of the device until it could no longer be retained in the vagina. This provides an incremental measurement of the relative strength or condition of the pelvic muscles. The device 70 provides the physician and patient greater flexibility in developing a pelvic muscle training program, specifically designed to meet the patient's individual needs. The different weight casings 86 and the different sized casings 72 allow a physician and/or user to custom fit the user with a device of the appropriate size and weight for exercising and/or testing of the pelvic muscles. It is to be understood, however, that even though numerous characteristics and advantages of the present invention have been set forth in the foregoing description, together with details of the structure and function of the invention, the disclosure is illustrative only, and changes may be made in detail, especially in matters of shape, size, materials and arrangement of parts within the principles of the invention to the full extent indicated by the broad generally meaning of the terms in which the appended claims are expressed.

Claims: WHAT IS CLAIMED IS: 1. An apparatus for testing and/or strengthening pelvic muscles, comprising: a hollow casing defining a cavity; and a plurality of inserts of differing weight positionable in the cavity defined by the casing. 2. /An apparatus in accordance with claim 1, wherein the inserts are made of the same material but have different configurations so as to have different weight. 3. 7Λn apparatus in accordance with claim 1, wherein the inserts have the same configuration but have different densities so as to have different weight. 4. /An apparatus in accordance with claim 1, wherein the inserts have at least one outer dimension which is the same for all the inserts. 5. An apparatus in accordance with claim 1, including a plurality of hollow casings of differing sizes. 6. An apparatus in accordance with claim 5, wherein the inner cavities of the hollow casings are of the same size. 7. An apparatus in accordance with claim 5, wherein the inner cavities of the hollow casing have at least one inner dimension which is the same for all the casings. 8. An apparatus in accordance with claim 1, wherein the hollow casing includes a top casing portion and a bottom casing portion which are threadedly attachable to each other. 9. An apparatus in accordance with claim 1, wherein the insert is concentrically disposed in the casing. 10. An apparatus in accordance with claim 1, wherein the inserts are molded about sub-inserts. 11. An apparatus in accordance with claim 1, wherein the inserts are separated into distinct and separate parts. 12. An apparatus in accordance with claim 1, wherein the casing includes first and second portions which are removably and non-destructively attachable to one another to form the casing, one of said inserts being integrally molded to one of said portions. 13. An apparatus in accordance with claim 1, wherein the casing includes separate and distinct first and second casing portions being threadedly attachable to one another to form the casing, a varying number of inserts being disposable in the casing. 14. An apparatus in accordance with claim 13, wherein one of the first and second portions includes a shaft portion, a plurality of inserts being receivable on the shaft portion, the shaft portion being threaded along at least a portion thereof for threaded attachment to the other of the first and second casing portions. 15. An apparatus in accordance with claim 14, wherein the inserts include a disk with an aperture for slidable receipt of the shaft portion. 16. An apparatus for testing and/or strengthening pelvic muscles, comprising: a two piece hollow casing defining a cavity and having a one piece top portion and a one piece bottom portion, the casing having a lesser diameter at a bottom end than at a top end, the top and bottom portions being threadedly interconnectable, the top portion being threaded on an inside surface and the bottom portion being threaded on an outside surface which is threadedly received in the top portion, the bottom portion defining a flange abuttingly receiving an end of the top portion, the top portion and the bottom portion having substantially the same diameter at the flange such the outer surface of the casing at the abutment of the top and bottom portions is relatively smooth; a set of inserts having different weights and sizes removably positionable in the external casing; the inserts having a head portion, a body portion, and a shoulder portion disposed between the head and body portions, the head portion being positionable in an inner cavity of the top portion of the external casing, the body portion being positionable in an inner cavity of the bottom portion of the external casing, the shoulder engaging a top end of the bottom portion to support the insert relative to the bottom portion, only one insert being positionable in the casing at any given time; and means attached to a second end of the bottom portion for grasping the casing. 17. An apparatus in accordance with claim 16, wherein the attachment means includes a cord secured in the bottom portion and extending through an aperture in the bottom portion. 18. 7An apparatus in accordance with claim 16, wherein the inserts have the same diameter at the shoulder portion and body portions of differing lengths. 19. An apparatus in accordance with claim 16, wherein the casing is tapered proximate the bottom end. 20. An apparatus in accordance with claim 16, wherein the inserts have a different sized body portion and the same size head portion. 21. An apparatus in accordance with claim 16, further including a second casing having a different external size than the first casing but having the same sized cavity. 22. A method of exercising pelvic muscles; comprising the steps of: selecting an appropriately weighted exercise device, the device including a two piece hollow casing selected from a plurality of casings of differing external size and an insert selected from a plurality of inserts of differing weights, the selecting step including selecting one of the inserts and placing the insert in the hollow casing; inserting the exercise device into the vagina of a user; retaining the exercise device in the vagina for a period of time; and wherein the step of selecting the two piece hollow casing includes the step of selecting a casing which best fits the user's vagina. 23. A method in accordance with claim 22, wherein the step of selecting the insert includes selecting the heaviest insert from the plurality of inserts which can be retained in the vagina.

Inventors: HARPSTEAD STANLEY D, HESTAD HUGH, HARPSTEAD, STANLEY, D., HESTAD, HUGH
Applicants: DACOMED CORP, HARPSTEAD STANLEY D, HESTAD HUGH, DACOMED CORPORATION, HARPSTEAD, STANLEY, D., HESTAD, HUGH
Application year: 1995
Main classification: A63B23
IPC codes: A61F5, A63B21, A63B23, A63B24